FDA.reportPublic FDA data

SpeediCath Compact

Primary DI
05708932024709
Brand
SpeediCath Compact
Company
Coloplast A/S
Model
M7354N
Catalog number
M7354N
Device description
SpeediCath Compact Male Kit sample pack. Compact with SpeediBag. 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.
Published
2016-09-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K143182000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143182000Speedicath Compact MaleColoplast A/S2015-01-20GBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708932024709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932024709057089320247095708932024709

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French
Catheter Gauge18French
Device Size Text, specify0
Outer Diameter4Millimeter
Outer Diameter6Millimeter

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)533-0464healthcarecs@coloplast.com

Regulatory Flags#

DUNS number
305524696
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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