MediPines Single Patient Use Breathing Circuit

FDA UDI

Class II (US FDA UDI)

by Medipines Corporation

Identity

Trade Name: MediPines Single Patient Use Breathing Circuit FDA UDI
Generic Name: Breathing mouthpiece, single-use FDA UDI
Device Name: Breathing Circuit Kit, Single Patient Use, 10 FDA UDI
Model / Reference: AGM316 FDA UDI
Description: Breathing Circuit Kit, Single Patient Use, 10 FDA UDI

Identifiers

Catalog Number: AGM316-10, AGM316-50, AGM316-100 FDA UDI
Primary DI / UDI-DI: 00860001261516 FDA UDI
510(k) Number: K180902 FDA UDI
FDA Product Code: CCL FDA UDI
CCK FDA UDI
BZL FDA UDI
GMDN Term: Breathing mouthpiece, single-use FDA UDI

Classification

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

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

MediPines Single Patient Use Breathing Circuit by Medipines Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Breathing mouthpiece, single-use.

Astraguard — SDI DIAGNOSTICS, INC. · Class II
Mouthpiece, Disposable, .900"OD, 2.50" L — A-M Systems, Inc. · Class I
Mouthpiece, Disposable, 1.125" ID, 2.5" L — A-M Systems, Inc. · Class I
PFT — Vitalograph Ireland, Ltd. · Class II
Disposable Mouthpiece 27mm OD — Vacumed · Class I
EasySpeak — Intersurgical Incorporated · Class I
All Flow Adult Disp Mthpc. — ALLIANCE TECH MEDICAL, INC. · Class I
PFT — Vitalograph Ireland, Ltd. · Class II

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 8532f342-0cca-4c3f-8cb9-f2766f31698c 37 fields · synced Jun 1, 2026