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Flow Regulator

FDA UDI

Class I (US FDA UDI)

by Covidien LP

Identity

Trade Name
Flow Regulator FDA UDI
Generic Name
Open-surgery adhesive/sealant applicator, dual-channel FDA UDI
Device Name
Flow Regulator FDA UDI
Model / Reference
FR-6065 FDA UDI
Description
Flow Regulator FDA UDI

Identifiers

Primary DI / UDI-DI
10884521057173 FDA UDI
FDA Product Code
CAN FDA UDI
GMDN Term
Open-surgery adhesive/sealant applicator, dual-channel FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.2700 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Open-surgery adhesive/sealant applicator, dual-channel

Flow Regulator by Covidien LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Open-surgery adhesive/sealant applicator, dual-channel.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI de9a785d-0f1e-4916-96ac-ffe45b06b457 34 fields · synced May 30, 2026