FDA.reportPublic FDA data

RUSCH

Primary DI
24026704666106
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN029795
Catalog number
390000
Device description
RUSCH CARE Premium Drain Bag
Published
2019-06-20
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
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
24026704666106PackageGS120In Commercial Distribution
14026704645708PreviousGS10
14026704666109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2402670466610624026704666106
1402670464570814026704645708
1402670466610914026704666109

GMDN Terms#

Term, Definition table
TermDefinition
Non-wearable urine collection bag, closed-endedA flexible plastic pouch designed to connect to a urinary catheter to collect discharged urine from a patient; it is not designed with an opening for urine drainage. The device is not directly attached to the patient and is disposed of when full. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501263FOOT URINE COLLECTORASSOMEDIKA, OOOKNX2026-05-26
04816415501270BEDSIDE URINE COLLECTORASSOMEDIKA, OOOKNX2026-05-26
50192253068601DoverCardinal Health 200, LLCKNX2026-01-16
50192253068717DoverCardinal Health 200, LLCKNX2026-01-16
50192253068724DoverCardinal Health 200, LLCKNX2026-01-16
50192253068731DoverCardinal Health 200, LLCKNX2026-01-16
50192253067987DoverCardinal Health 200, LLCKNX2026-01-15
50192253068014DoverCardinal Health 200, LLCKNX2026-01-15
50192253068212DoverCardinal Health 200, LLCKNX2026-01-15
16974500612586Disposable Urinary Drainage BagGCMEDICA ENTERPRISE LTD.(WUXI)KNX2025-08-07
30840330701793ProCureTwin Med, LLCKNX2025-05-31
30840330701809ProCureTwin Med, LLCKNX2025-05-31
50192253027790DoverCardinal Health 200, LLCKNX2025-04-01
50192253028230DoverCardinal Health 200, LLCKNX2025-04-01
50192253032169DoverCardinal Health 200, LLCKNX2025-04-01
50192253030059DoverCardinal Health 200, LLCKNX2025-04-01
50192253027943DoverCardinal Health 200, LLCKNX2025-03-20
50850045818390TruCathHR PHARMACEUTICALS INC.KNX2025-02-17
50850045818406TruCathHR PHARMACEUTICALS INC.KNX2025-02-17
50192253028568DoverCardinal Health 200, LLCKNX2024-12-20
50192253028520DoverCardinal Health 200, LLCKNX2024-12-20
50192253028537DoverCardinal Health 200, LLCKNX2024-12-20
50192253028544DoverCardinal Health 200, LLCKNX2024-12-20
50192253028469DoverCardinal Health 200, LLCKNX2024-12-20
50192253031124DoverCardinal Health 200, LLCKNX2024-12-20
50192253028551DoverCardinal Health 200, LLCKNX2024-12-20
50192253027936DoverCardinal Health 200, LLCKNX2024-11-04
50192253028285DoverCardinal Health 200, LLCKNX2024-11-04
50192253028490DoverCardinal Health 200, LLCKNX2024-11-04
50192253031445DoverCardinal Health 200, LLCKNX2024-11-04