Double Insufflation Bulb

FDA UDI

Class II (US FDA UDI)

by Heine Optotechnik GmbH & Co. KG

Identity

Trade Name: DOUBLE INSUFFLATION BULB FDA UDI
Generic Name: Endoscope inflation bulb FDA UDI
Model / Reference: 000 FDA UDI

Identifiers

Catalog Number: E-000.18.105 FDA UDI
Primary DI / UDI-DI: 04053755125999 FDA UDI
FDA Product Code: GCM FDA UDI
GMDN Term: Endoscope inflation bulb FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscope inflation bulb

Double Insufflation Bulb by Heine Optotechnik GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscope inflation bulb.

Bariatric Air Syringe — TOOLS FOR SURGERY, LLC · Class I
Colorectal Air Syringe-LP EX — TOOLS FOR SURGERY, LLC · Class I
Colorectal Air Syringe-OP EX — TOOLS FOR SURGERY, LLC · Class I
Gyrus ACMI — Gyrus Acmi, Inc. · Class II
Colorectal Air Syringe-OP — TOOLS FOR SURGERY, LLC · Class I
Disposable Bulb & Bladder — HEALTHMARK INDUSTRIES CO., INC. · Class I
FLY — Shanghai FLY Medical Devices Co., Ltd. · Class I
Sterile Bulb & Bladder — HEALTHMARK INDUSTRIES CO., INC. · Class I

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: Heine Optotechnik GmbH & Co. KG

Sources (1)

FDA UDI a6401c3a-7187-4739-956e-fd011f18814c 34 fields · synced Jun 6, 2026