Identity
- Trade Name
- nSpire Health FDA UDI
- Generic Name
- Pulmonary function testing kit FDA UDI
- Device Name
- KoKo Pulmonary Function Filter Kit, White with Rubber Mouthpiece for KoKo Px, HDpft and Collins PFT Systems. FDA UDI
- Model / Reference
- KoKo Filter Kit FDA UDI
- Description
- KoKo Pulmonary Function Filter Kit, White with Rubber Mouthpiece for KoKo Px, HDpft and Collins PFT Systems. FDA UDI
Identifiers
- Catalog Number
- K022462 FDA UDI
- Primary DI / UDI-DI
- 10852417003689 FDA UDI
- FDA Product Code
- BYP FDA UDICAH FDA UDI
- GMDN Term
- Pulmonary function testing kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5620 FDA UDI868.5260 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulmonary function testing kit
nSpire Health by Nspire Health, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary function testing kit.
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- Pulmoguard — SDI DIAGNOSTICS, INC. · Class II
- Polytech Filter — POLYTECHNIC RESOURCES, INC. · Class II
- KIT, MIR DISPOSABLE TURBINE & VBMAX30E — A-M Systems, Inc. · Class II
- All Flow — ALLIANCE TECH MEDICAL, INC. · Class II
- ABC Mouthpiece and Filter Kit — Aktina Corp.
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 I | Pending data |
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Manufacturer
- Manufacturer
- Nspire Health, Inc.
Sources (1)
- FDA UDI ded738e0-3b3a-4a86-8ff3-4cd9263dfeb5 34 fields · synced Jun 8, 2026