FDA.report

SpeediCath Standard

Primary DI
05701780209076
Brand
SpeediCath Standard
Company
Coloplast A/S
Model
28482
Catalog number
28482
Device 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.
Published
2020-03-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GBMCATHETER, URETHRAL

Product Code Classifications

CodeDeviceSpecialtyClass
GBMCatheter, UrethralGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05701780209076PackageGS1100In Commercial Distribution
05701780209236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05701780209076057017802090765701780209076
05701780209236057017802092365701780209236

GMDN Terms

TermDefinition
Single-administration urethral catheterization kit, single-useA sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge10French
Catheter Working Length13.9Inch
Catheter Working Length35Centimeter
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Do not use if package is damaged and consult IFU.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)533-0464healthcarecs@coloplast.com

Regulatory Flags

DUNS number
305524696
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05708932778268SpeediCath Flex Set28941289412026-02-05
05708932778275SpeediCath Flex Set28942289422026-02-05
05708932778282SpeediCath Flex Set28946289462026-02-05
03600040963876ColoplastAC5904AC59042026-01-30
03600040963944ColoplastAC5905AC59052026-01-30
03600040964026ColoplastAC5906AC59062026-01-30
03600040964095ColoplastAC5907AC59072026-01-30
03600040964170ColoplastAC5908AC59082026-01-30
03600040964231ColoplastAC5909AC59092026-01-30
03600040964293ColoplastAC5910AC59102026-01-30
03600040964361ColoplastAC5911AC59112026-01-30
03600040964415ColoplastAC5912AC59122026-01-30
03600040964651ColoplastAC5C07AC5C072026-01-30
03600040965894ColoplastACP205ACP2052026-01-30
03600040965948ColoplastACP206ACP2062026-01-30
03600040966006ColoplastACP207ACP2072026-01-30
03600040966068ColoplastACP208ACP2082026-01-30
03600040966136ColoplastACP303ACP3032026-01-30
03600040966228ColoplastACP304ACP3042026-01-30
03600040966310ColoplastACP305ACP3052026-01-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10610075097439OnliHOLLISTER INCORPORATEDGBM2026-02-01
10610075097446OnliHOLLISTER INCORPORATEDGBM2026-02-01
10610075097453OnliHOLLISTER INCORPORATEDGBM2026-02-01
20610075091922VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092585VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092592VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092608VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092615VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092622VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092639VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092646VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092653VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092660VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092677VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092684VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092691VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092707VaProHOLLISTER INCORPORATEDGBM2026-01-30
20192253058434DoverCardinal Health 200, LLCGBM2025-01-23
20192253058441DoverCardinal Health 200, LLCGBM2025-01-23
20192253058458DoverCardinal Health 200, LLCGBM2025-01-23
20192253058465DoverCardinal Health 200, LLCGBM2025-01-23
20192253058472DoverCardinal Health 200, LLCGBM2025-01-23
20192253058489DoverCardinal Health 200, LLCGBM2025-01-23
20192253058496DoverCardinal Health 200, LLCGBM2025-01-23
20192253058502DoverCardinal Health 200, LLCGBM2025-01-23
20192253058519DoverCardinal Health 200, LLCGBM2025-01-23
20192253058526DoverCardinal Health 200, LLCGBM2025-01-23
20192253058533DoverCardinal Health 200, LLCGBM2025-01-23
20192253058540DoverCardinal Health 200, LLCGBM2025-01-23
20610075104394InstantCathHOLLISTER INCORPORATEDGBM2024-07-09