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Transcend

FDA UDI

Class I (US FDA UDI)

by Somnetics International, Inc

Identity

Trade Name
Transcend FDA UDI
Generic Name
Inspiratory/expiratory limb respiratory tubing, single-use FDA UDI
Model / Reference
WhisperSoft FDA UDI

Identifiers

Catalog Number
505002 FDA UDI
Primary DI / UDI-DI
M950505002 FDA UDI
FDA Product Code
BYX FDA UDI
GMDN Term
Inspiratory/expiratory limb respiratory tubing, single-use 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

No

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, single-use

Transcend by Somnetics International, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Inspiratory/expiratory limb respiratory tubing, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Somnetics International, Inc

Sources (1)

  • FDA UDI a71333d6-db76-4224-84aa-7b95cf77d922 34 fields · synced May 30, 2026