FDA.reportPublic FDA data

SpeediCath Compact

Primary DI
05708932543941
Brand
SpeediCath Compact
Company
Coloplast A/S
Model
28520
Catalog number
28520
Device description
SpeediCath Compact Set. Urinary catheter with attached bag for intermittent catheterization. Ready to use coated catheter. Nelaton. Female. Length: 3.
Published
2016-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBMCATHETER, URETHRAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBMCatheter, UrethralGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121457000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121457000SPEEDICATH COMPACT SET (12 FR)Coloplast Corp.2012-10-02GBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708932024600PackageGS13In Commercial Distribution
05708932024761PackageGS15In Commercial Distribution
05708932543934PackageGS120In Commercial Distribution
05708932543941PackageGS13In Commercial Distribution
05708932543927PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932024600057089320246005708932024600
05708932024761057089320247615708932024761
05708932543934057089325439345708932543934
05708932543941057089325439415708932543941
05708932543927057089325439275708932543927

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral drainage catheterA sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge10French
Catheter Working Length3.5Inch
Catheter Working Length9Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length3.5Inch
Outer Diameter3.3Millimeter
Total Volume750Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if sterile barrier is damaged
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00This way up. Keep away from sunlight. Do not use if package is damaged and consult IFU.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00762123030196Conveen Security+21346213462022-03-11
05701780385411SenSura Mio Convex18541185412026-06-08
05701780385442SenSura Mio Convex18542185422026-06-08
05701780385473SenSura Mio Convex18543185432026-06-08
05701780385503SenSura Mio Convex18544185442026-06-08
05701780385541SenSura Mio Convex18545185452026-06-08
05701780385572SenSura Mio Convex18546185462026-06-08
05701780385602SenSura Mio Convex18547185472026-06-08
05701780385633SenSura Mio Convex18548185482026-06-08
05701780385664SenSura Mio Convex18549185492026-06-08
05701780385701SenSura Mio Convex18550185502026-06-08
05701780385732SenSura Mio Convex18551185512026-06-08
05701780385763SenSura Mio Convex18540185402026-06-08
05708932487047Peristeen29125291252016-09-20
05708932135184Conveen05050050502023-01-17
05701780434133SenSura Mio1229101229102026-04-30
05701780434508SenSura Mio1229201229202026-04-30
05701780434843SenSura Mio1229601229602026-04-30
05701780435239SenSura Mio1229701229702026-04-30
05701780436328SenSura Mio Convex1367901367902026-04-30

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