Identity
- Trade Name
- ProChamber Assembly FDA UDI
- Generic Name
- Medicine chamber spacer, reusable FDA UDI
- Device Name
- PROCHAMBER WITH SMALL SILICONE MASK 50-pack FDA UDI
- Model / Reference
- 00 FDA UDI
- Description
- PROCHAMBER WITH SMALL SILICONE MASK 50-pack FDA UDI
Identifiers
- Catalog Number
- 1117489 FDA UDI
- Primary DI / UDI-DI
- 00383730000695 FDA UDI
- FDA Product Code
- BWF FDA UDI
- GMDN Term
- Medicine chamber spacer, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5690 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Medicine chamber spacer, reusable
ProChamber Assembly by Respironics Respiratory Drug Delivery (uk) Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Respironics Respiratory Drug Delivery (uk) Ltd
Sources (1)
- FDA UDI fc6d3811-c7fc-4a25-a2cd-edd66d34c83f 35 fields · synced May 30, 2026