FDA.report

Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter

Primary DI
10801741025263
Brand
Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter
Company
C. R. Bard, Inc.
Model
1758SI24
Catalog number
1758SI24
Device description
Bardex® Lubri-Sil® I.C. All-Silicone Coated 5 cc Foley Catheter
Published
2016-03-04
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
EZLCATHETER, RETENTION TYPE, BALLOON

Product Code Classifications

CodeDeviceSpecialtyClass
EZLCatheter, Retention Type, BalloonGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741025263PackageGS112In Commercial Distribution
00801741025266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174102526310801741025263
00801741025266008017410252668017410252660801741025266

GMDN Terms

TermDefinition
Indwelling urethral drainage catheter, antimicrobialA sterile, flexible tube with an inflatable balloon on its distal tip intended to be inserted through the urethra and retained in the urinary bladder to function as an indwelling therapeutic device for urinary drainage. It is used for a variety of conditions causing urinary retention (e.g., postoperative, obstruction). Commonly known as a Foley catheter, it is inserted by trained staff and may have a bent tip (coude) to facilitate insertion. It is also coated with an antibiotic or antimicrobial agent to help prevent catheter-associated urinary tract infection (CAUTI). 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
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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