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SpeediCath Compact

FDA UDI

Class II (US FDA UDI)

by Coloplast A/S

Identity

Trade Name
SpeediCath Compact FDA UDI
Generic Name
Single-administration urethral drainage catheter FDA UDI
Device Name
SpeediCath Compact with SpeediBag sample pack. Urinary catheter for intermittent catheterization. Ready to use coated catheter. Nelaton. Male. Incl. 5 sterile catheters and 5 x non-sterile urine collection bag. Rx-only. FDA UDI
Model / Reference
M7442N FDA UDI
Description
SpeediCath Compact with SpeediBag sample pack. Urinary catheter for intermittent catheterization. Ready to use coated catheter. Nelaton. Male. Incl. 5 sterile catheters and 5 x non-sterile urine collection bag. Rx-only. FDA UDI

Identifiers

Catalog Number
M7442N FDA UDI
Primary DI / UDI-DI
05708932024754 FDA UDI
510(k) Number
K210250 FDA UDI
FDA Product Code
GBM FDA UDI
GMDN Term
Single-administration urethral drainage catheter 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 — 12 French FDA UDI

SpeediCath Compact 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 7b245053-c1da-4e1c-a407-4e4865fcefa1 39 fields · synced Jun 8, 2026