New Image

FDA UDI

Class I (US FDA UDI)

by Hollister Incorporated

Identity

Trade Name: New Image FDA UDI
Generic Name: Intestinal ostomy bag/support kit FDA UDI
Device Name: Colostomy/Ileostomy Kit, FlexWear FDA UDI
Model / Reference: 19353 FDA UDI
Description: Colostomy/Ileostomy Kit, FlexWear FDA UDI

Identifiers

Catalog Number: 19353 FDA UDI
Primary DI / UDI-DI: 10610075198617 FDA UDI
FDA Product Code: PQE FDA UDI
GMDN Term: Intestinal ostomy bag/support kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.5900 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

Yes

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

Dimensions & Sizes

Size: Lumen/Inner Diameter — 57 Millimeter FDA UDI
Lumen/Inner Diameter — 44 Millimeter FDA UDI

Category: Intestinal ostomy bag/support kit

New Image by Hollister Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Hollister Incorporated

Sources (1)

FDA UDI 56038ed9-6ccf-4da2-859e-fa5b3a2e0b37 36 fields · synced Jun 9, 2026