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Heating tube set for insufflation, single use

FDA UDI

Class II (US FDA UDI)

by W.O.M. World of Medicine GmbH

Identity

Trade Name
Heating tube set for insufflation, single use FDA UDI
Generic Name
Endoscopic insufflation tubing set, single-use FDA UDI
Model / Reference
INSFHTDTUB FDA UDI

Identifiers

Primary DI / UDI-DI
04056702008772 FDA UDI
510(k) Number
K153513 FDA UDI
FDA Product Code
HIF FDA UDI
OSV FDA UDI
GMDN Term
Endoscopic insufflation tubing set, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.1730 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

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

Yes

FDA UDI

Category: Endoscopic insufflation tubing set, single-use

Heating tube set for insufflation, single use by W.O.M. World of Medicine GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic insufflation tubing set, single-use.

Cleared under the same submission

K153513 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
W.O.M. World of Medicine GmbH

Sources (1)

  • FDA UDI 8f7705d6-93ee-4598-9f66-08c492c33cd2 33 fields · synced May 30, 2026