Identity
- Trade Name
- ProCure FDA UDI
- Generic Name
- Rebreathing oxygen face mask FDA UDI
- Device Name
- ProCure Oxygen Mask Medium-Concentration w/7' Tubing Universal Connector Adult FDA UDI
- Model / Reference
- 1006436 FDA UDI
- Description
- ProCure Oxygen Mask Medium-Concentration w/7' Tubing Universal Connector Adult FDA UDI
Identifiers
- Catalog Number
- 1006436 FDA UDI
- Primary DI / UDI-DI
- 10840330704417 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- Rebreathing oxygen face mask FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5580 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 7 Feet FDA UDI
Category: Rebreathing oxygen face mask
ProCure by Twin Med, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ClasStar, GanzGesMask, NIV, AAV, L — Drägerwerk AG & Co. KGaA · Class IIa
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- Oro-Nasal Mask — HANS RUDOLPH, INC. · Class IIa
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
- Twin Med, LLC
Sources (1)
- FDA UDI f7a311d2-f1d9-410e-994f-6984200fb469 36 fields · synced Jun 1, 2026