Identity
- Trade Name
- nSpire Health FDA UDI
- Generic Name
- Pulmonary function testing kit FDA UDI
- Device Name
- KoKo Standard Pulmonary Function Filter Kit, White with Cardboard Mouthpiece. 26.3mm ID x 30mm OD for use with MicroMedical, Vitalograph, Schiller, MultiSpiro/Creative Biomedics, MIR. Box of 100. FDA UDI
- Model / Reference
- KoKo Filter Kit FDA UDI
- Description
- KoKo Standard Pulmonary Function Filter Kit, White with Cardboard Mouthpiece. 26.3mm ID x 30mm OD for use with MicroMedical, Vitalograph, Schiller, MultiSpiro/Creative Biomedics, MIR. Box of 100. FDA UDI
Identifiers
- Catalog Number
- 851010 FDA UDI
- Primary DI / UDI-DI
- 10852417003733 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
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- 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 bd7fc640-b488-4e75-a0f1-2f37f6fc0bbb 34 fields · synced May 30, 2026