Identity
- Trade Name
- CPR Bag Reusable FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, reusable FDA UDI
- Model / Reference
- 10-50735 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30641043507357 FDA UDI
- 510(k) Number
- K970756 FDA UDI
- FDA Product Code
- BTM FDA UDI
- GMDN Term
- Pulmonary resuscitator, manual, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5915 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulmonary resuscitator, manual, reusable
CPR Bag Reusable by Mercury Enterprises, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pulmonary resuscitator, manual, reusable.
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- Life Support Products — Allied Medical LLC · Class II
- LIFESAVER — GaleMed Xiamen Co., Ltd. · Class II
- EASY GRIP — O-Two Medical Technologies Inc · Class II
- Life Support Products (LSP) — Allied Medical LLC · Class II
- NeoNatalie Resuscitator (US) — Laerdal Medical Corp. · Class II
Cleared under the same submission
K970756 also covers:
- CPR Bag Reusable — MERCURY ENTERPRISES, INC.
- CPR Bag Reusable — MERCURY ENTERPRISES, INC.
- CPR Bag Reusable — MERCURY ENTERPRISES, INC.
- CPR Bag Reusable — MERCURY ENTERPRISES, INC.
- CPR Bag Reusable — MERCURY ENTERPRISES, INC.
- CPR Bag Reusable — MERCURY ENTERPRISES, INC.
- CPR Bag Reusable — MERCURY ENTERPRISES, INC.
- CPR Bag Reusable — MERCURY ENTERPRISES, INC.
- CPR Bag Reusable — MERCURY ENTERPRISES, INC.
- CPR Bag Reusable — MERCURY ENTERPRISES, INC.
- CPR Bag Reusable — MERCURY ENTERPRISES, INC.
- CPR Bag Reusable — MERCURY ENTERPRISES, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Mercury Enterprises, Inc.
Sources (1)
- FDA UDI 2157008d-64e5-4df6-b628-1374c375215c 34 fields · synced Jun 1, 2026