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Dynaris

FDA UDI

Class II (US FDA UDI)

by Incoba LLC

Identity

Trade Name
Dynaris FDA UDI
Generic Name
Oxygen therapy conserving regulator FDA UDI
Model / Reference
902001 FDA UDI

Identifiers

Primary DI / UDI-DI
00850027997001 FDA UDI
510(k) Number
K200401 FDA UDI
FDA Product Code
NFB FDA UDI
GMDN Term
Oxygen therapy conserving regulator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5905 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Oxygen therapy conserving regulator

Dynaris by Incoba LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oxygen therapy conserving regulator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Incoba LLC

Sources (1)

  • FDA UDI 98e22e8e-3496-4e68-8273-48273792c49f 33 fields · synced May 30, 2026