FDA.reportPublic FDA data

Bard® Adapter and Tubing

Primary DI
10801741045742
Brand
Bard® Adapter and Tubing
Company
C. R. Bard, Inc.
Model
000538
Catalog number
000538
Device description
Bard® Adapter and Tubing for Leg Bags to Male External Catheter or Foley Catheter
Published
2016-08-22
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
10801741045742PackageGS150In Commercial Distribution
00801741045745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174104574210801741045742
00801741045745008017410457458017410457450801741045745

GMDN Terms#

Term, Definition table
TermDefinition
Urethral/ureteral catheter connector, sterileA small, sterile, connecting device intended to create a mechanical union between the proximal end of urethral and/or ureteral catheter and an external device (e.g., irrigation/vacuum unit, syringe, urine drainage bag) to enable infusion, drainage, or other procedures to be performed through the lumen of the catheter; it has no additional functions (e.g., not a two-way valve). It may also be intended to connect a urinary condom catheter (a penis sheath-type catheter) to a urine drainage bag. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)526-4455medical.services@crbard.com

Regulatory Flags#

DUNS number
016898496
Device count
1
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
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
00801741011191N/A006172P006172P2015-06-29
00801741011207N/A006173P006173P2015-06-29
00801741011214N/A006221P006221P2015-06-29
00801741011221N/A006225P006225P2015-06-29
00801741011238N/A006241P006241P2015-06-29
00801741011245N/A006242P006242P2015-06-29
00801741011269NBIH™ Temporary Pacing Electrode Catheter007150P007150P2015-06-29
00801741011276NBIH™ Temporary Pacing Electrode Catheter007151P007151P2015-06-29
00801741011283NBIH™ Temporary Pacing Electrode Catheter007152P007152P2015-06-29
00801741011290NBIH™ Temporary Pacing Electrode Catheter007153P007153P2015-06-29
00801741011306GOETZ™ Temporary Pacing Electrode Catheter007154P007154P2015-06-29
00801741011313GOETZ™ Temporary Pacing Electrode Catheter007155P007155P2015-06-29
00801741011320GOETZ™ Temporary Pacing Electrode Catheter007156P007156P2015-06-29
00801741011337GOETZ™ Temporary Pacing Electrode Catheter007157P007157P2015-06-29
00801741011344NBIH™ Temporary Pacing Electrode Catheter007250P007250P2015-06-29
00801741011351NBIH™ Temporary Pacing Electrode Catheter007253P007253P2015-06-29
00801741011368NBIH™ Temporary Pacing Electrode Catheter007406P007406P2015-06-29
00801741011375NBIH™ Temporary Pacing Electrode Catheter007417P007417P2015-06-29
00801741011474NBIH™ Temporary Pacing Electrode Catheter057152P057152P2015-06-29
00801741011481NBIH™ Temporary Pacing Electrode Catheter057153P057153P2015-06-29

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