Identity
- Trade Name
- PrimeAire EUDAMEDFDA UDI
- Generic Name
- Medicine chamber spacer, reusable FDA UDI
- Device Name
- PrimeAire Valved Holding Chamber EUDAMEDPLASTIC DUAL VALVED HOLDING CHAMBER FDA UDI
- Model / Reference
- 1114 EUDAMEDFDA UDI
- Description
- PLASTIC DUAL VALVED HOLDING CHAMBER FDA UDI
Identifiers
- Catalog Number
- 1114 FDA UDI
- Primary DI / UDI-DI
- 00383480000051 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00383480000051 EUDAMED
- 510(k) Number
- K992722 FDA UDI
- FDA Product Code
- CAF FDA UDI
- EMDN Code
- R9080 RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES 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
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
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
Yes
FDA UDI
Category: Gas-sampling/monitoring respiratory tubing, single-use
PrimeAire by Thayer Medical Corporation — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00383480000051 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Thayer Medical Corporation
- EUDAMED SRN
- US-MF-000026197
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED eee59f20-1e17-4e0d-87c8-60acead0071c 61 fields · synced Jul 14, 2026
- FDA UDI 71303c12-74e6-41f4-9598-0293f0fa766f 36 fields · synced May 30, 2026