Identity
- Trade Name
- Headgear reus.,SI,large FDA UDI
- Generic Name
- Anaesthesia mask strap, reusable FDA UDI
- Model / Reference
- MP01558 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048675035725 FDA UDI
- FDA Product Code
- BSJ FDA UDI
- GMDN Term
- Anaesthesia mask strap, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5550 FDA UDI
- Commercial Distribution
- Not 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
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
MR Unsafe FDA UDI
Headgear reus., SI, large by Drägerwerk AG & Co. KGaA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Drägerwerk AG & Co. KGaA
Sources (1)
- FDA UDI 19a70ffd-36ac-4c78-a2f4-a1c5ed6365d7 34 fields · synced Jun 1, 2026