Data / Medical devices / Mexico / S & Mohr America, S.A. DE C.V.
S & Mohr America, S.A. DE C.V.: FDA-registered device maker in ESTADO DE MEXICO Ciudad de Mexico, Mexico, 5 510(k) clearances
S & Mohr America, S.A. DE C.V. is registered with the FDA (registration 3020777588) in ESTADO DE MEXICO Ciudad de Mexico, Mexico. It lists 18 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 16, 2020. 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
- 3020777588
- Address
- Circuito De La Industria Poniente Lote 10 C Parque Ind. El Cerrillo, ESTADO DE MEXICO Ciudad de Mexico, Mexico, 52000
- Owner or operator
- Meditera Tibbi Malzeme Sanayi ve Ticaret A.S. (9099982)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 5, 2007
- Registered through
- 2026
- Brand names listed
- 005060 22 MM BREATHING CIRCUIT / LEAK PORT, 005519- 15mm Dual Limb Breathing Circuit, 005520- 22mm Dual Limb Breathing Circuit, 007387 22MM DISPOSABLE BREATHING CIRCUIT WITH EXHALATION VALVE, 007616 IPBB BREATHING CIRCUIT (BREAS), 007857 15 MM DISP PT CIRCUIT W EX VAL, 009118 Disposable 22mm Single Limb (1.8m), 009119 Disposable 15mm Single Limb (1.8m) and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| March 16, 2020 | K192713 | Altera Filter and HME/Filter | CAH | Substantially Equivalent | Meditera Tibbi Malzeme San VE Tic AS | accessdata.fda.gov |
| December 11, 2014 | K141389 | SAPPHIRE INFUSION PUMP | FRN | Substantially Equivalent | Q Core Medical , Ltd. | accessdata.fda.gov |
| August 5, 2014 | K141834 | SAPPHIRE ADMINISTRATION SET | FPA | Substantially Equivalent | Q Core Medical , Ltd. | accessdata.fda.gov |
| October 17, 2013 | K123049 | SAPPHIRE INFUSION PUMP | FRN | Substantially Equivalent | Q Core Medical , Ltd. | accessdata.fda.gov |
| September 13, 2011 | K102483 | SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 | CAH | Substantially Equivalent | Sunset Healthcare Solutions, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 5, 2023 | 91562 | Class III | Ongoing | abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Breathing Circuit with Face Mask - Child/Adult Small REF BC21088 abm Respiratory Care Standart Breathing C | Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027" | accessdata.fda.gov |
Compare with other makers
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Humidifier Nebulizer Kit
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- All makers of Mask, Oxygen, Non-Rebreathing
- All makers of Bag, Reservoir
- All makers of Mouthpiece, Breathing
Updated February 22, 2023. 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.