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Blue Diamond™

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
Blue Diamond™ FDA UDI
Generic Name
Catheter/overtube balloon inflator, single-use FDA UDI
Model / Reference
00884450016084 FDA UDI

Identifiers

Primary DI / UDI-DI
00884450016084 FDA UDI
FDA Product Code
DXT 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

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: Catheter/overtube balloon inflator, single-use

Blue Diamond is a single-use, manual syringe/plunger-based catheter/overtube balloon inflator designed for medical procedures. It features an analogue/digital gauge/screen for monitoring pressure and a locking mechanism to ensure precise inflation/deflation. This device has been in commercial distribution since September 2016 and is available for purchase from Merit Medical Systems, Inc.

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 fac5d85b-3fc7-440d-87ef-6198bd54893f 32 fields · synced Oct 6, 2026