FDA.report

Bard® Urethral Catheterization Tray with Red Rubber Catheter

Primary DI
10801741040228
Brand
Bard® Urethral Catheterization Tray with Red Rubber Catheter
Company
C. R. Bard, Inc.
Model
774415
Catalog number
774415
Device description
Bard® Urethral Catheterization Tray with Red Rubber Catheter
Published
2016-07-29
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
EYBCATHETER, URETERAL, GASTRO-UROLOGY

Product Code Classifications

CodeDeviceSpecialtyClass
EYBCatheter, Ureteral, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741040228PackageGS120In Commercial Distribution
00801741040221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174104022810801741040228
00801741040221008017410402218017410402210801741040221

GMDN Terms

TermDefinition
Single-administration urethral drainage catheterA sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge15French

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
true
No natural rubber latex
false
Sterilization required before use
false

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