FDA.report

SpeediCath Standard

Primary DI
05701780209199
Brand
SpeediCath Standard
Company
Coloplast A/S
Model
28481
Catalog number
28481
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
05701780209199PackageGS1100In Commercial Distribution
05701780209151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05701780209199057017802091995701780209199
05701780209151057017802091515701780209151

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 Gauge8French
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

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