FDA.report

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

Primary DI
10801741039918
Brand
Bardex® Lubri-Sil® I.C. All-Silicone Temp Sensing Foley Catheter
Company
C. R. Bard, Inc.
Model
119316M
Catalog number
119316M
Device description
Bardex® Lubri-Sil® I.C. 400 Series Temperature Sensing All-Silicone 5 cc Foley Catheter
Published
2016-03-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
10801741039918PackageGS112In Commercial Distribution
00801741039911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174103991810801741039918
00801741039911008017410399118017410399110801741039911

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 Gauge16French

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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