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6 Month CPAP Kit

FDA UDI

Class I (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name
6 Month CPAP Kit FDA UDI
Generic Name
Inspiratory/expiratory limb respiratory tubing, reusable FDA UDI
Device Name
(1)TUB06NS (6)CF1010-1 (1)CF1010F-1 FDA UDI
Model / Reference
AASH001CPAP6KIT FDA UDI
Description
(1)TUB06NS (6)CF1010-1 (1)CF1010F-1 FDA UDI

Identifiers

Primary DI / UDI-DI
00848530093440 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

6 Month CPAP Kit 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

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Manufacturer

Manufacturer
SUNSET HEALTHCARE SOLUTIONS, Inc.

Sources (1)

  • FDA UDI 3c167fe4-fc24-4426-b57f-8195c0a5ea10 34 fields · synced May 31, 2026