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Trach O-Flex™

FDA UDI

Class I (US FDA UDI)

by Cutting Edge Hc Brands Llc

Identity

Trade Name
Trach O-Flex™ FDA UDI
Generic Name
Straight/elbow breathing circuit connector, single-use FDA UDI
Device Name
Trach O-Flex Tracheostomy Flex Connector 15mm O.D. X 22mm O.D. ADULT FDA UDI
Model / Reference
RTG-19001 FDA UDI
Description
Trach O-Flex Tracheostomy Flex Connector 15mm O.D. X 22mm O.D. ADULT FDA UDI

Identifiers

Catalog Number
RTG-19001 FDA UDI
Primary DI / UDI-DI
00850108006127 FDA UDI
FDA Product Code
BZO FDA UDI
GMDN Term
Straight/elbow breathing circuit connector, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5975 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 15 Millimeter FDA UDI
Outer Diameter — 22 Millimeter FDA UDI

Category: Straight/elbow breathing circuit connector, single-use

Trach O-Flex™ by Cutting Edge Hc Brands Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Straight/elbow breathing circuit connector, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cutting Edge Hc Brands Llc

Sources (1)

  • FDA UDI dcd175ef-d772-445b-a062-a4b741140604 36 fields · synced May 31, 2026