← Back to catalogue

CPAP Tubing

FDA UDI

Class I (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name
CPAP Tubing FDA UDI
Generic Name
Inspiratory/expiratory limb respiratory tubing, reusable FDA UDI
Device Name
CPAP Tubing 4 Foot 19mm I.D. with 22mm Cuffs Gray FDA UDI
Model / Reference
MCT04 FDA UDI
Description
CPAP Tubing 4 Foot 19mm I.D. with 22mm Cuffs Gray FDA UDI

Identifiers

Primary DI / UDI-DI
00848530099565 FDA UDI
FDA Product Code
BYX FDA UDI
GMDN Term
Inspiratory/expiratory limb respiratory tubing, 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: Inspiratory/expiratory limb respiratory tubing, reusable

CPAP Tubing by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Inspiratory/expiratory limb respiratory tubing, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
SUNSET HEALTHCARE SOLUTIONS, Inc.

Sources (1)

  • FDA UDI e78155f9-733e-4c9f-9504-0d404c656023 34 fields · synced Jun 8, 2026