Niv Angled Mouthpiece With Notch 22m/15f

FDA UDI

Class I (US FDA UDI)

by Intersurgical Incorporated

Identity

Trade Name: NIV ANGLED MOUTHPIECE WITH NOTCH 22M/15F FDA UDI
Generic Name: Breathing mouthpiece, single-use FDA UDI
Device Name: NIV ANGLED MOUTHPIECE WITH NOTCH 22M/15F FDA UDI
Model / Reference: 1938000 FDA UDI
Description: NIV ANGLED MOUTHPIECE WITH NOTCH 22M/15F FDA UDI

Identifiers

Primary DI / UDI-DI: 05030267120505 FDA UDI
FDA Product Code: BYP FDA UDI
GMDN Term: Breathing mouthpiece, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5620 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

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Breathing mouthpiece, single-use

Niv Angled Mouthpiece With Notch 22m/15f by Intersurgical Incorporated — 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: Intersurgical Incorporated

Sources (1)

FDA UDI f88b15e1-86ff-47b0-93f7-d063b58e8b1b 34 fields · synced May 30, 2026