FDA.report

Bard® Foley Catheter Silicone Coated

Primary DI
10801741039734
Brand
Bard® Foley Catheter Silicone Coated
Company
C. R. Bard, Inc.
Model
266724
Catalog number
266724
Device description
Bard®Foley Catheter, Silicone Coated, 30cc Balloon
Published
2016-06-25
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
10801741039734PackageGS112In Commercial Distribution
00801741039737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174103973410801741039734
00801741039737008017410397378017410397370801741039737

GMDN Terms

TermDefinition
Indwelling urethral drainage catheterA sterile, flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, to function as an indwelling therapeutic device for urinary drainage; it might be designed to also allow for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge24French

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
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
true
No natural rubber latex
false
Sterilization required before use
false

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10801741121965Bard® Robinson Catheter003712000371202016-07-23
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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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