Data / Medical devices / United States / Bemis Manufacturing Co.

Bemis Manufacturing Co.: FDA-registered device maker in Sheboygan Falls, WI, United States, 7 510(k) clearances

Name: Bemis Manufacturing Co. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bemis Manufacturing Co. is registered with the FDA (registration 2133713) in Sheboygan Falls, WI, United States. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated February 11, 1997. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2133713
FEI number: 3000209940
Address: W2940 Old County Road PP, Sheboygan Falls, WI, United States, 53085
Owner or operator: BEMIS MANUFACTURING COMPANY (9008164)
Roles: Manufacturer, Repackager or relabeler
First device listed: July 23, 1992
Registered through: 2026
Brand names listed: 1000cc Quick Fit Suction Liner, 1500cc Quick Fit Suction Liner, 2003ST 030 Hydrophobic canister Stryker 5450-851-012, 3000cc Quick Fit Suction Liner, Adapter, Aquilex Fluid Control System, Aquilex Fluid Control System AQL-BEMIS, Bemis One Quart Phlebotomy Container and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2	Manufacturer	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Manufacturer	accessdata.fda.gov
Container, Sharps	MMK	2	Manufacturer	accessdata.fda.gov
Container, Specimen, Non-Sterile	NNI	1	Manufacturer	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 11, 1997	K964858	BEMIS TWO GALLON CHEMOTHERAPY CONTAINER	MMK	Substantially Equivalent	Bemis Mfg. Co.	accessdata.fda.gov
March 28, 1996	K960525	BEMIS ONE QUART PHLEBOTOMY CONTAINER (PART NUMBER 100)	MMK	Substantially Equivalent	Bemis Mfg. Co.	accessdata.fda.gov
November 27, 1995	K953797	SHARPS DISPOSAL CONTAINERS	MMK	Substantially Equivalent	Bemis Mfg. Co.	accessdata.fda.gov
June 2, 1995	K950340	IGHT AND ELEVEN GALLON SHARPS AND CHEMOTHERAPY CONTAINERS	MMK	Substantially Equivalent	Bemis Mfg. Co.	accessdata.fda.gov
May 23, 1994	K941664	SHARP DISPOSAL CONTAINERS WALL SAFE	MMK	Substantially Equivalent	Bemis Mfg. Co.	accessdata.fda.gov
May 23, 1994	K931664	SHARPS DISPOSABLE CONTAINERS	MMK	Substantially Equivalent	Bemis Mfg. Co.	accessdata.fda.gov
December 20, 1977	K771737	SUCTION CANISTER	GCX	Substantially Equivalent	Bemis Health Care	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 25, 2004	28497	Not yet classified	Terminated	Bemis Two-Gallon Sharps Container, Models #, #, and #. (The only difference between the models is in color. Model is yellow, Model is beige and Model is red. )	The closure flap of the recalled sharps containers have two tabs that fit into slots on the cover for final closure and locking but some of the covers have one of the tabs that will not fit into the designated slot because the slot is occluded with plastic.	accessdata.fda.gov

Compare with other makers

Updated July 20, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.