FDA.report

Bard® Pediatric Urine Meter Catheterization Tray

Primary DI
10801741040433
Brand
Bard® Pediatric Urine Meter Catheterization Tray
Company
C. R. Bard, Inc.
Model
895605
Catalog number
895605
Device description
Bard® Pediatric Urine Meter Catheterization Tray with Polyurethane Catheter
Published
2016-06-13
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

Related Records

Contact Domains

Product Codes

CodeName
KODCATHETER, UROLOGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
KODCatheter, UrologicalGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741040433PackageGS110In Commercial Distribution
00801741040436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174104043310801741040433
00801741040436008017410404368017410404360801741040436

GMDN Terms

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

TypeValueUnit
Catheter Gauge5French

Sterilization Methods

Method

Contacts

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
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
false
No natural rubber latex
true
Sterilization required before use
false

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10801741121965Bard® Robinson Catheter003712000371202016-07-23
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10801741121989Bard® Robinson Catheter003716000371602016-07-23
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10801741122047Bard® Robinson Catheter003728000372802016-07-23
10801741122061Bard® Robinson Catheter003732000373202016-07-23
10801741122078Bard® Robinson Catheter003734000373402016-07-23
10801741122092Bard® Robinson Catheter003736000373602016-07-23
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10801741122115Bard® Robinson Catheter003740000374002016-07-23
10801741122122Bard® Robinson Catheter003742000374202016-07-23
10801741122139Bard® Robinson Catheter003744000374402016-07-23
10801741122146Bard® Robinson Catheter003746000374602016-07-23
10801741122153Bard® Robinson Catheter003748000374802016-07-23

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