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SpeediCath Standard

FDA UDI

Class II (US FDA UDI)

by Coloplast A/S

Identity

Trade Name
SpeediCath Standard FDA UDI
Generic Name
Single-administration urethral catheterization kit, single-use FDA UDI
Device Name
Catheter with accessories containing: 1 ready to use coated catheter, 1 pair of gloves, 1 drape, 2 aseptic cleansing wipes, 1 SpeediBag® 700 ml urine bag. FDA UDI
Model / Reference
28504 FDA UDI
Description
Catheter with accessories containing: 1 ready to use coated catheter, 1 pair of gloves, 1 drape, 2 aseptic cleansing wipes, 1 SpeediBag® 700 ml urine bag. FDA UDI

Identifiers

Catalog Number
28504 FDA UDI
Primary DI / UDI-DI
05708932020473 FDA UDI
FDA Product Code
GBM FDA UDI
GMDN Term
Single-administration urethral catheterization kit, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5130 FDA UDI
Commercial Distribution
Not 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

Yes

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

Dimensions & Sizes

Size
Catheter Gauge — 16 French FDA UDI
Catheter Working Length — 6.3 Inch FDA UDI
Catheter Working Length — 16 Centimeter FDA UDI

SpeediCath Standard by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coloplast A/S

Sources (1)

  • FDA UDI 9b8b9dd3-f82f-4704-846b-68c4593a9f7e 38 fields · synced Jun 8, 2026