nSpire Health

FDA UDI

Class I (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 Foam Nose Clips for use with KoKo, KoKo SX, Legend (I&II), KoKo DigiDoser and KoKo Trek Spirometers. Box of 100. FDA UDI
Model / Reference: KoKo Filter Kit FDA UDI
Description: KoKo Standard Blue Filter kit with Foam Nose Clips for use with KoKo, KoKo SX, Legend (I&II), KoKo DigiDoser and KoKo Trek Spirometers. Box of 100. FDA UDI

Identifiers

Catalog Number: 810005 FDA UDI
Primary DI / UDI-DI: 10852417003610 FDA UDI
FDA Product Code: BXJ FDA UDI
CAH FDA UDI
GMDN Term: Pulmonary function testing kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.6225 FDA UDI
868.5260 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 I — 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 I	Pending data

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Manufacturer

Manufacturer: Nspire Health, Inc.

Sources (1)

FDA UDI 6bf9c760-9386-4bdc-a120-a74ccca0f87a 34 fields · synced Jun 1, 2026