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Flow Control Tubing

FDA UDI

Class II (US FDA UDI)

by Go Medical Industries Pty. Ltd.

Identity

Trade Name
Flow Control Tubing FDA UDI
Generic Name
Mechanical infusion pump administration set FDA UDI
Model / Reference
FCT 30mL/72h FDA UDI

Identifiers

Catalog Number
FCT30-72h FDA UDI
Primary DI / UDI-DI
09350902001089 FDA UDI
510(k) Number
K910007 FDA UDI
FDA Product Code
FRN FDA UDI
GMDN Term
Mechanical infusion pump administration set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5725 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Mechanical infusion pump administration set

Flow Control Tubing is a single-use, mechanical infusion pump administration set designed to be used with a variety of implantable devices. This device provides the necessary components for intermittent or continuous infusion of medication, including a reservoir, plastic tubing, and check valve. Its use in conjunction with an implantable device allows for precise control over the flow rate and volume of medication, ensuring optimal treatment outcomes.

Similar devices

Also classified as Mechanical infusion pump administration set.

Cleared under the same submission

K910007 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Go Medical Industries Pty. Ltd.

Sources (1)

  • FDA UDI 4d12830e-c3fd-4ef8-8838-d973ed2b313e 34 fields · synced Jun 28, 2026