Identity
- Trade Name
- OP - First aid series FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, reusable FDA UDI
- Model / Reference
- OP0201194 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974686052087 FDA UDI
- FDA Product Code
- BYP FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation mask, reusable 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
No
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 mask, reusable
OP - First aid series by Yiwu Ori-Power Medtech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiopulmonary resuscitation mask, reusable.
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- MICROTEK — Microtek Medical LLC · Class II
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- Pocket Mask w/O2, SP (Black IE) — Laerdal Medical Corp. · Class II
- HEADSTAR — Headstar Medical Products Co., Ltd. · Class I
- MICROTEK — Microtek Medical LLC · Class II
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
- Yiwu Ori-Power Medtech Co., Ltd.
Sources (1)
- FDA UDI 2473a107-5b4f-460d-adfb-f2be0ce1b022 32 fields · synced Jun 8, 2026