Identity
- Trade Name
- Headgear L, Box 5 FDA UDI
- Generic Name
- Nasal oxygen cannula, CPAP FDA UDI
- Model / Reference
- MP03884 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048675419334 FDA UDI
- FDA Product Code
- CAT FDA UDI
- GMDN Term
- Nasal oxygen cannula, CPAP FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5340 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nasal oxygen cannula, CPAP
Headgear L, Box 5 by Drägerwerk AG & Co. KGaA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal oxygen cannula, CPAP.
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- Inca — CooperSurgical, Inc. · Class II
- Inca — CooperSurgical, Inc. · Class II
- Inspire — Inspiration Healthcare, Ltd. · Class I
- Argyle — Cardinalhealth · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- Infant Flow™ — VYAIRE MEDICAL, INC. · Class II
- VYGON — Vygon 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (1)
- FDA UDI d8f4163a-f7df-465f-a38c-e11cdca76826 33 fields · synced May 31, 2026