Identity
- Trade Name
- First Aid Only FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mouthpiece/cover FDA UDI
- Device Name
- CPR keychain masks box of 30 FDA UDI
- Model / Reference
- J5095 FDA UDI
- Description
- CPR keychain masks box of 30 FDA UDI
Identifiers
- Catalog Number
- J5095 FDA UDI
- Primary DI / UDI-DI
- 00092265150958 FDA UDI
- FDA Product Code
- BYP FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation mouthpiece/cover FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiopulmonary resuscitation mouthpiece/cover
First Aid Only by Acme United Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary resuscitation mouthpiece/cover.
- MedSource Face Shield — MEDSOURCE INTERNATIONAL LLC · Class I
- Elite CPR Face Shield — MEDSOURCE INTERNATIONAL LLC · Class I
- Elite CPR Face Shield — MEDSOURCE INTERNATIONAL LLC · Class I
- MedSource Face Shield — MEDSOURCE INTERNATIONAL LLC · Class I
- Keybo Technologies Ltd. CPR Face Shield — Keybo Technologies Ltd · Class I
- First Aid Only — ACME UNITED CORP. · Class I
- First Aid Only — ACME UNITED CORP. · Class I
- First Aid Only — ACME UNITED CORP. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Acme United Corp.
Sources (1)
- FDA UDI 7da3d060-e884-4083-b232-50bff738cc93 35 fields · synced Jun 20, 2026