Inflation Pack Model 3002

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name: Inflation Pack Model 3002 FDA UDI
Generic Name: Catheter/overtube balloon inflator, single-use FDA UDI
Model / Reference: 00884450141359 FDA UDI

Identifiers

Catalog Number: 8700-000778-01 FDA UDI
Primary DI / UDI-DI: 00884450141359 FDA UDI
FDA Product Code: OEQ 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Catheter/overtube balloon inflator, single-use

Inflation Pack Model 3002 by Merit Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

GENOSS Inflator B40 — Genoss · Class II
AngioDynamics — NAVILYST MEDICAL, INC.
NuVent™ — MEDTRONIC XOMED, INC. · Class I
QL Disposable Inflation Device — Atrion Medical Products, Inc. · Class II
Mannequin™ Endoventricular Shaper — KDL MEDICAL, INC. · Class II
AngioDynamics — NAVILYST MEDICAL, INC.
Encore 40 Inflation Device — Atrion Medical Products, Inc. · Class II
GM-30 Inflation Device — Infraredx, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Merit Medical Systems, Inc.

Sources (1)

FDA UDI 33bdf8bd-24b8-4826-98ab-1c45634c730f 33 fields · synced Jun 9, 2026