FDA.report

Bardia® Foley Catheter Insertion Tray

Primary DI
10801741018272
Brand
Bardia® Foley Catheter Insertion Tray
Company
C. R. Bard, Inc.
Model
802130
Catalog number
802130
Device description
Bardia® Foley Catheter Insertion Tray
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
OHRCatheter care tray

Product Code Classifications

CodeDeviceSpecialtyClass
OHRCatheter Care TrayGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741018272PackageGS120In Commercial Distribution
00801741018275PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174101827210801741018272
00801741018275008017410182758017410182750801741018275

GMDN Terms

TermDefinition
Urethral catheterization support kit, urinary drainageA collection of sterile, non-surgically invasive devices intended to assist a healthcare professional to insert a urethral catheter (not included) into the urinary bladder, typically for drainage of urine; some types may also be intended for catheter removal. It typically includes forceps, dressings, gloves, and drapes; it does not include pharmaceuticals. This is a single-use device.

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
false
No natural rubber latex
true
Sterilization required before use
false

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00801741231001PureWickPW300PW3002026-02-06
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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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