Vapotherm

FDA UDI

Class I (US FDA UDI)

by Vapotherm Inc.

Identity

Trade Name: Vapotherm FDA UDI
Generic Name: Nasal oxygen cannula, basic FDA UDI
Device Name: Neonatal Nasal Cannula, India Version FDA UDI
Model / Reference: MN1100B-IN FDA UDI
Description: Neonatal Nasal Cannula, India Version FDA UDI

Identifiers

Primary DI / UDI-DI: 00841737104438 FDA UDI
FDA Product Code: CAT FDA UDI
GMDN Term: Nasal oxygen cannula, basic FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5340 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Nasal oxygen cannula, basic

Vapotherm by Vapotherm 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: Vapotherm Inc.

Sources (1)

FDA UDI 3602557c-134b-4839-9fc8-42c348a4d3fd 33 fields · synced Jun 7, 2026