FDA.reportPublic FDA data

SureStep™ Foley Tray System Bard® Lubricath Foley

Primary DI
10801741073936
Brand
SureStep™ Foley Tray System Bard® Lubricath Foley
Company
C. R. Bard, Inc.
Model
A800361
Catalog number
A800361
Device description
SureStep® Foley Tray System Bard® Lubricath® Foley Catheter Tray & 2000 ml Drainage Bag
Published
2015-12-06
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
EZCCATHETER, COUDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZCCatheter, CoudeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741073936PackageGS110In Commercial Distribution
00801741073939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174107393610801741073936
00801741073939008017410739398017410739390801741073939

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral catheterization kitA collection of sterile devices that includes an indwelling urethral catheter (commonly known as a Foley catheter), gloves, lubricating gel, and other related accessories intended for the drainage of urine from the bladder. The catheter has an inflatable balloon at the distal tip for retention in the urinary bladder after its insertion through the urethra, where it usually functions as an indwelling therapeutic device for urinary incontinence or as a means to void for non-ambulatory patients. The catheter will be applied by trained staff and may or may not be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French

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
false
HCT/P
false
Kit
true
Combination product
true
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
true
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
10801741218788SureStep Foley Tray SystemC. R. Bard, Inc.EZC2024-05-13
10801741218832SureStep Foley Tray SystemC. R. Bard, Inc.EZC2024-05-13
10801741171663BardiaC. R. Bard, Inc.EZC2023-08-21
20801741171677BardiaC. R. Bard, Inc.EZC2023-08-21
20801741171684BardiaC. R. Bard, Inc.EZC2023-08-21
20801741171691BardiaC. R. Bard, Inc.EZC2023-08-21
20801741171707BardiaC. R. Bard, Inc.EZC2023-08-21
10801741171717BardiaC. R. Bard, Inc.EZC2023-08-21
10801741171724BardiaC. R. Bard, Inc.EZC2023-08-21
10801741171731BardiaC. R. Bard, Inc.EZC2023-08-21
10801741171748BardiaC. R. Bard, Inc.EZC2023-08-21
20801741171752BardiaC. R. Bard, Inc.EZC2023-08-21
10801741218795SureStep Foley Tray SystemC. R. Bard, Inc.EZC2022-03-23
10801741218801SureStep Foley Tray SystemC. R. Bard, Inc.EZC2022-03-23
10801741218825SureStep Foley Tray SystemC. R. Bard, Inc.EZC2022-03-23
00852141007895OneCath LubricatedCOMPACTCATH, INC.EZC2021-09-25
10801741183192SureStep Intermittent Catheter TrayC. R. Bard, Inc.EZC2019-11-13
00852141007321COMPACTCATH - LiteCOMPACTCATH, INC.EZC2019-07-05
10801741147477SureStep Foley Tray System with Bardex Lubricath Foley CatheterC. R. Bard, Inc.EZC2019-05-23
00852141007307COMPACTCATH - LiteCOMPACTCATH, INC.EZC2019-04-24
00817643020230Hopkins Medical Products®HOPKINS UNIFORM COMPANYEZC2018-09-28
00817643020247Hopkins Medical Products®HOPKINS UNIFORM COMPANYEZC2018-09-28
00817643020285Hopkins Medical Products®HOPKINS UNIFORM COMPANYEZC2018-09-28
00852141007123COMPACTCATHCOMPACTCATH, INC.EZC2018-09-12
00852141007208OneCathCOMPACTCATH, INC.EZC2018-09-12
00852141007215OneCathCOMPACTCATH, INC.EZC2018-09-12
00852141007246OneCathCOMPACTCATH, INC.EZC2018-09-12
00852141007338OneCathCOMPACTCATH, INC.EZC2018-09-12
44026704031816RUSCHTELEFLEX INCORPORATEDEZC2016-09-16
24026704031829RUSCHTELEFLEX INCORPORATEDEZC2016-09-16