nSpire Health

FDA UDI

Class II (US FDA UDI)

by Nspire Health, Inc.

Identity

Trade Name: nSpire Health FDA UDI
Generic Name: Pulmonary function testing kit FDA UDI
Device Name: KoKo Standard Blue Filter Kit with Nose Clip and Rubber Mouthpiece for use with KoKo Sx, KoKo Legend, KoKo Digidoser and KoKo Trek Spirometers. Box of 50. FDA UDI
Model / Reference: KoKo Filter Kit FDA UDI
Description: KoKo Standard Blue Filter Kit with Nose Clip and Rubber Mouthpiece for use with KoKo Sx, KoKo Legend, KoKo Digidoser and KoKo Trek Spirometers. Box of 50. FDA UDI

Identifiers

Catalog Number: 810580 FDA UDI
Primary DI / UDI-DI: 10852417003627 FDA UDI
FDA Product Code: CAH FDA UDI
BYP FDA UDI
BXJ FDA UDI
GMDN Term: Pulmonary function testing kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5260 FDA UDI
868.5620 FDA UDI
868.6225 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Pulmonary function testing kit

nSpire Health by Nspire Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 II	Pending data

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Manufacturer

Manufacturer: Nspire Health, Inc.

Sources (1)

FDA UDI 70259289-6a20-4ab0-843a-e586325abe20 34 fields · synced Jun 8, 2026