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Oxygen Delivery Adapter for T-HME

FDA UDI

Class I (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name
Oxygen Delivery Adapter for T-HME FDA UDI
Generic Name
Low-pressure tubing connector, reusable FDA UDI
Device Name
Oxygen Delivery Adapter for T-HME (1/pack) FDA UDI
Model / Reference
RES027A FDA UDI
Description
Oxygen Delivery Adapter for T-HME (1/pack) FDA UDI

Identifiers

Catalog Number
RES027A FDA UDI
Primary DI / UDI-DI
00848530062354 FDA UDI
FDA Product Code
BYX FDA UDI
GMDN Term
Low-pressure tubing connector, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Low-pressure tubing connector, reusable

Oxygen Delivery Adapter for T-HME by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Low-pressure tubing connector, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SUNSET HEALTHCARE SOLUTIONS, Inc.

Sources (1)

  • FDA UDI d857f0cf-63fe-414a-9062-49858f09bc1e 37 fields · synced Jun 1, 2026