Identity
- Trade Name
- Adult Mask / Large EUDAMEDMASK - OC Advanced FDA UDI
- Generic Name
- Medicine chamber spacer, reusable FDA UDI
- Device Name
- Silicone Face Mask EUDAMEDOC Advanced Adult Large Mask, 10-pack FDA UDI
- Model / Reference
- HS81311-010 EUDAMED00 FDA UDI
- Description
- OC Advanced Adult Large Mask, 10-pack FDA UDI
Identifiers
- Catalog Number
- HS81311-010 FDA UDI
- Primary DI / UDI-DI
- 00383730001203 EUDAMEDFDA UDI
- Basic UDI-DI
- 038373BM263XF EUDAMED
- FDA Product Code
- CAF FDA UDI
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
- GMDN Term
- Medicine chamber spacer, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Anaesthesia face mask, single-use
Adult Mask / Large by Respironics, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Anaesthesia face mask, single-use.
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- King Mask — Ambu A/S · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 038373BM263XF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 983359ff-e847-4598-8cd9-4622fd76d988 61 fields · synced May 30, 2026
- FDA UDI fcfa1276-5d5d-4071-a62b-85792e06f273 35 fields · synced May 30, 2026