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basixTOUCH™

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
basixTOUCH™ FDA UDI
Generic Name
Catheter/overtube balloon inflator, single-use FDA UDI
Model / Reference
00884450621301 FDA UDI

Identifiers

Catalog Number
IN8152/C FDA UDI
Primary DI / UDI-DI
00884450621301 FDA UDI
FDA Product Code
PTM FDA UDI
GMDN Term
Catheter/overtube balloon inflator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1650 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

Yes

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

Category: Catheter/overtube balloon inflator, single-use

Introducing the basixTOUCH, a cutting-edge medical device designed to precisely inflate and regulate catheter balloons during invasive procedures. With its single-use design, this innovative device ensures accurate pressure control and minimizes the risk of complications. The basixTOUCH is equipped with a manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue/digital gauge/screen for monitoring pressure, and a locking mechanism to prevent accidental deflation.

Similar devices

Also classified as Catheter/overtube balloon inflator, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merit Medical Systems, Inc.

Sources (1)

  • FDA UDI fa146f20-e7b9-4513-b1a8-d493b0ccebb5 33 fields · synced Oct 6, 2026