FDA.report

Bardex® Urethral Catheter Robinson Model

Primary DI
10801741033503
Brand
Bardex® Urethral Catheter Robinson Model
Company
C. R. Bard, Inc.
Model
056110
Catalog number
056110
Device description
Bardex® Urethral Catheter Robinson Model
Published
2016-06-10
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
10801741033503PackageGS112In Commercial Distribution
00801741033506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174103350310801741033503
00801741033506008017410335068017410335060801741033506

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 Gauge10French

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
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00801741231001PureWickPW300PW3002026-02-06
00801741231018PureWickPW300CASEPW300CASE2026-02-06
10801741121941Bard® Robinson Catheter003708000370802016-07-23
10801741121965Bard® Robinson Catheter003712000371202016-07-23
10801741121972Bard® Robinson Catheter003714000371402016-07-23
10801741121989Bard® Robinson Catheter003716000371602016-07-23
10801741121996Bard® Robinson Catheter003718000371802016-07-23
10801741122016Bard® Robinson Catheter003722000372202016-07-23
10801741122023Bard® Robinson Catheter003724000372402016-07-23
10801741122030Bard® Robinson Catheter003726000372602016-07-23
10801741122047Bard® Robinson Catheter003728000372802016-07-23
10801741122061Bard® Robinson Catheter003732000373202016-07-23
10801741122078Bard® Robinson Catheter003734000373402016-07-23
10801741122092Bard® Robinson Catheter003736000373602016-07-23
10801741122108Bard® Robinson Catheter003738000373802016-07-23
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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