MediPines Gas Exchange Monitor Starter Kit

FDA UDI

Class II (US FDA UDI)

by Medipines Corporation

Identity

Trade Name: MediPines Gas Exchange Monitor Starter Kit FDA UDI
Generic Name: Nose clip, single-use FDA UDI
Device Name: Breathing Circuit and Nose Clip, Single Use, 10 pieces each FDA UDI
Model / Reference: MPSK10 FDA UDI
Description: Breathing Circuit and Nose Clip, Single Use, 10 pieces each FDA UDI

Identifiers

Catalog Number: MPSK10 FDA UDI
Primary DI / UDI-DI: 00860001261530 FDA UDI
510(k) Number: K180902 FDA UDI
FDA Product Code: BZL FDA UDI
CCK FDA UDI
CCL FDA UDI
GMDN Term: Nose clip, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1730 FDA UDI
868.1400 FDA UDI
868.1720 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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Breathing mouthpiece, single-use Nose clip, single-use

MediPines Gas Exchange Monitor Starter Kit by Medipines Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nose clip, single-use.

Disposable PFT Nose Clip with Rubber Pads — A-M Systems, Inc. · Class I
Noseclip, Disposable , White, Foam Pad — A-M Systems, Inc. · Class I
Multicolor noseclip 50/bag — Vacumed · Class I
Snuffer noseclip 1000/bx — Vacumed · Class I
Disposable Blue PFT Nose Clip with Foam Pads — A-M Systems, Inc. · Class I
Disposable Blue PFT Nose Clip with Foam Pads — A-M Systems, Inc. · Class I
Curaplex — BOUND TREE MEDICAL, LLC · Class I
Curaplex — TRI-ANIM HEALTH SERVICES, INC. · Class I

Cleared under the same submission

K180902 also covers:

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: Medipines Corporation

Sources (1)

FDA UDI 3f083d2e-fb64-45f8-a03a-8c22c45d8f0d 37 fields · synced May 30, 2026