Medium pediatric mask with 22mm connector for use with Philips Respironics valv…
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Medium pediatric mask with 22mm connector for use with Philips Respironics valved holding chambers, Silicone mask 18 months - 6 years EUDAMEDMASK - OC Advanced FDA UDI
- Generic Name
- Medicine chamber spacer, reusable FDA UDI
- Device Name
- Silicone Face Mask EUDAMEDOC Advanced Medium Pediatric Mask, Single Unit FDA UDI
- Model / Reference
- HS81210EU-001 EUDAMED00 FDA UDI
- Description
- OC Advanced Medium Pediatric Mask, Single Unit FDA UDI
Identifiers
- Catalog Number
- HS81210EU-001 FDA UDI
- Primary DI / UDI-DI
- 00383730001166 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
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Anaesthesia face mask, single-use
Medium pediatric mask with 22mm connector for use with Philips Respironics valv… by Respironics Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Anaesthesia face mask, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 e2e318db-34aa-46a4-ad43-f32ef2beaeaa 61 fields · synced Jul 11, 2026
- FDA UDI 9346e544-8b83-491e-9cb4-e972c384a3f0 35 fields · synced May 30, 2026