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Indeflator

FDA UDI

Class II (US FDA UDI)

by Abbott Vascular

Identity

Trade Name
Indeflator FDA UDI
Generic Name
Catheter/overtube balloon inflator, single-use FDA UDI
Device Name
COPILOT Kit includes Bleedback Control Valve 20/30 INDEFLATOR Inflation Device 30 atm 20 cc / Guide Wire Introducer / Torque Device FDA UDI
Model / Reference
1003327 FDA UDI
Description
COPILOT Kit includes Bleedback Control Valve 20/30 INDEFLATOR Inflation Device 30 atm 20 cc / Guide Wire Introducer / Torque Device FDA UDI

Identifiers

Catalog Number
1003327 FDA UDI
Primary DI / UDI-DI
08717648013973 FDA UDI
FDA Product Code
DTL FDA UDI
GMDN Term
Catheter/overtube balloon inflator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4290 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

Indeflator by Abbott Vascular — 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
Abbott Vascular

Sources (1)

  • FDA UDI 97e98d29-a6bc-4430-9fd0-70b23bfffa18 36 fields · synced May 30, 2026