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2-lumen Cystometry Pack

FDA UDI

Class II (US FDA UDI)

by Laborie Medical Technologies Canada ULC

Identity

Trade Name
2-lumen Cystometry Pack FDA UDI
Generic Name
Urodynamic manometric catheter, non-electronic FDA UDI
Device Name
with Rectal Split Balloon with Introducer, 6F FDA UDI
Model / Reference
9021T1141 FDA UDI
Description
with Rectal Split Balloon with Introducer, 6F FDA UDI

Identifiers

Primary DI / UDI-DI
00627825007566 FDA UDI
FDA Product Code
FEN FDA UDI
GMDN Term
Urodynamic manometric catheter, non-electronic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1620 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Urodynamic manometric catheter, non-electronic

2-lumen Cystometry Pack by Laborie Medical Technologies Canada ULC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urodynamic manometric catheter, non-electronic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Laborie Medical Technologies Canada ULC

Sources (1)

  • FDA UDI ecd8687c-8831-4385-8f78-dceada982186 33 fields · synced May 30, 2026