FDA.reportPublic FDA data

COMPACTCATH Extension Tube

Primary DI
00852141007840
Brand
COMPACTCATH Extension Tube
Company
COMPACTCATH, INC.
Model
1903-1832
Catalog number
1903-1832
Device description
The CompactCath extension tube is connect with CompactCath Lubricated Intermittent Urinary Catheter when needed.
Published
2021-02-02
Public version status
New
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
KNXCollector, Urine, (And Accessories) For Indwelling Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852141007847PrimaryGS10
00852141007840Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085214100784710852141007847
00852141007840008521410078408521410078400852141007840

GMDN Terms#

Term, Definition table
TermDefinition
Urinary catheter/drainage bag connection facilitatorA non-sterile device intended to provide a patient or healthcare provider a means of rapid and leak-proof bag exchange during replacement of a urine bag that connects to an in situ urinary catheter. It is typically made of plastic and consists of two separate blades, each with a scissors-like handle and which terminates distally in a half-cylinder channel. The distal ends of the blades are inserted into the stretchable connector of the urine bag to form a full-cylinder channel through which the proximal end of an indwelling ureteral or urinary condom catheter is inserted to form a connection with the bag, after which the blades are removed. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French
Length16Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (888) 933-2284support@compactcath.com

Regulatory Flags#

DUNS number
054765780
Device count
25
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
10810053920036OneCath Hydro2031-16142031-16142021-10-23
10810053920043OneCath Hydro2031-08122031-08122021-10-23
10810053920081OneCath Hydro2032-16142032-16142021-10-23
00810053920039OneCath Hydro2031-16142031-16142021-10-23
00810053920046OneCath Hydro2031-08122031-08122021-10-23
00810053920084OneCath Hydro2032-16142032-16142021-10-23
00852141007468OneCath201-1612 (30) 1612 (30 pack)2021-09-25
00852141007475OneCath201-1614 (30)1614(30)2021-09-25
00852141007925OneCath Lubricated2041-16142041-16142021-09-25
00852141007949OneCath Lubricated2042-16142042-16142021-09-25
00852141007079OneCath201-1612 (30) 1612 (30 pack)2021-09-25
00852141007109OneCath201-1614 (30)1614(30)2021-09-25
00852141007871OneCath Lubricated2041-16142041-16142021-09-25
00852141007895OneCath Lubricated2042-16142042-16142021-09-25
10852141007847COMPACTCATH Extension Tube1903-18321903-18322021-02-02
10852141007724COMPACTCATH - Lite1011-16161011-16162019-09-01
10852141007731COMPACTCATH - Lite1012-16161012-16162019-09-01
00852141007383COMPACTCATH - Lite1011-16121011-16122019-08-01
00852141007321COMPACTCATH - Lite1012-16141012-16142019-07-05
00852141007307COMPACTCATH - Lite1002-16141002-16142019-04-24

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Primary DI, Brand, Company table
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