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OLYMPUS EndoTherapy™ Inflation Device for Biliary

FDA UDI

Class II (US FDA UDI)

by Atrion Medical Products, Inc.

Identity

Trade Name
OLYMPUS EndoTherapy™ Inflation Device for Biliary FDA UDI
Generic Name
Catheter/overtube balloon inflator, single-use FDA UDI
Device Name
Inflation Device Atrion Part Number 96296: 20mL, 15atm FDA UDI
Model / Reference
QL2015 FDA UDI
Description
Inflation Device Atrion Part Number 96296: 20mL, 15atm FDA UDI

Identifiers

Catalog Number
MAJ-1381 FDA UDI
Primary DI / UDI-DI
04953170195167 FDA UDI
FDA Product Code
KOE FDA UDI
MAV FDA UDI
GMDN Term
Catheter/overtube balloon inflator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5520 FDA UDI
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

Yes

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: Catheter/overtube balloon inflator, single-use

OLYMPUS EndoTherapy™ Inflation Device for Biliary by Atrion Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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
Atrion Medical Products, Inc.

Sources (1)

  • FDA UDI 6ca1cb41-2250-4e2c-8b6e-78ed7f917f29 35 fields · synced Jun 12, 2026