Identity
- Trade Name
- LIVESAVER FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, reusable FDA UDI
- Device Name
- MANUAL RESUSCITATOR, DURABLE, ADULT FDA UDI
- Model / Reference
- HD-5340 FDA UDI
- Description
- MANUAL RESUSCITATOR, DURABLE, ADULT FDA UDI
Identifiers
- Catalog Number
- 5340 FDA UDI
- Primary DI / UDI-DI
- 24710810093184 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
Livesaver by GaleMed Xiamen Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- GaleMed Xiamen Co., Ltd.
Sources (1)
- FDA UDI 88766cc7-d5ab-43c4-8106-db9a4f24bc8b 35 fields · synced May 30, 2026