FDA.report

Bardex® I.C. Complete Care® Foley Tray

Primary DI
10801741019422
Brand
Bardex® I.C. Complete Care® Foley Tray
Company
C. R. Bard, Inc.
Model
320018A
Catalog number
320018A
Device description
Bardex® I.C. Complete Care® Foley Tray
Published
2016-07-26
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
MJCCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Product Code Classifications

CodeDeviceSpecialtyClass
MJCCatheter, Urological (Antimicrobial) And AccessoriesGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741019422PackageGS110In Commercial Distribution
00801741019425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174101942210801741019422
00801741019425008017410194258017410194250801741019425

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 Gauge18French

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
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

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