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PED/ADU Airway Adapter w Mouthpiece
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 6421-00
Identity
- Trade Name
- PED/ADU Airway Adapter w Mouthpiece EUDAMEDAirway Adapter FDA UDI
- Generic Name
- Carbon dioxide cuvette, single-use FDA UDI
- Device Name
- Airway Adapters EUDAMEDPediatric/Adult Airway Adapter with Mouthpiece FDA UDI
- Model / Reference
- 6421-00 EUDAMEDFDA UDI
- Description
- Pediatric/Adult Airway Adapter with Mouthpiece FDA UDI
Identifiers
- Catalog Number
- 6421-00 FDA UDI
- Primary DI / UDI-DI
- 00884838014053 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM629TG EUDAMED
- FDA Product Code
- BZA FDA UDI
- EMDN Code
- Z1203020485 GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Carbon dioxide cuvette, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5810 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
PED/ADU Airway Adapter w Mouthpiece by Respironics Novametrix, LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0884838BM629TG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Respironics Novametrix, LLC
- EUDAMED SRN
- US-MF-000007951
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 4090b93d-1357-4505-9a1d-a54ce02dd43e 61 fields · synced Jul 11, 2026
- FDA UDI 9e56207b-22be-484d-b99b-8590b586a9d7 36 fields · synced May 30, 2026