Identity
- Trade Name
- nSpire Health FDA UDI
- Generic Name
- Whole-body plethysmograph FDA UDI
- Device Name
- All-digital, tempered glass and metal body plethysmograph features fail-safe automatic release of the cabin door locking mechanism, patient intercom, and motorized sensor arm, providing superior performance, patient comfort and convenience. FDA UDI
- Model / Reference
- BpD FDA UDI
- Description
- All-digital, tempered glass and metal body plethysmograph features fail-safe automatic release of the cabin door locking mechanism, patient intercom, and motorized sensor arm, providing superior performance, patient comfort and convenience. FDA UDI
Identifiers
- Catalog Number
- K004300 FDA UDI
- Primary DI / UDI-DI
- 00852417003446 FDA UDI
- 510(k) Number
- K852102 FDA UDI
- FDA Product Code
- CCM FDA UDI
- GMDN Term
- Whole-body plethysmograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1750 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Whole-body plethysmograph
nSpire Health by Nspire Health, Inc. — 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
- Nspire Health, Inc.
Sources (1)
- FDA UDI 697d70e3-52f4-4ac7-bc63-75cfc411ef95 35 fields · synced May 30, 2026