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 White Filter Kit with Nose Clip and Rubber Mouthpiece 30mm ID x 33.5mm OD for use with Jaeger and ZAN. Box of 50. FDA UDI
Model / Reference: KoKo Filter Kit FDA UDI
Description: KoKo Standard White Filter Kit with Nose Clip and Rubber Mouthpiece 30mm ID x 33.5mm OD for use with Jaeger and ZAN. Box of 50. FDA UDI

Identifiers

Catalog Number: 877580 FDA UDI
Primary DI / UDI-DI: 10852417003757 FDA UDI
FDA Product Code: BXJ FDA UDI
BYP 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
868.5620 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

Similar devices

Also classified as Pulmonary function testing kit.

PFT Kit E, VBMax30E — A-M Systems, Inc. · Class II
PFT KIT F, DISPOSABLE, VBMax34S — A-M Systems, Inc. · Class II
PFT Kit F, VBMax 36E — A-M Systems, Inc. · Class II
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Nspire Health, Inc.

Sources (1)

FDA UDI 9daa4627-bee9-4bf8-99e3-1d25d2789642 34 fields · synced May 30, 2026