FDA.report

Bard® 350ml Urine Meter Foley Tray with Bard EZ-Lok™ Sampling Port

Primary DI
10801741029124
Brand
Bard® 350ml Urine Meter Foley Tray with Bard EZ-Lok™ Sampling Port
Company
C. R. Bard, Inc.
Model
902600
Catalog number
902600
Device description
Bard® 350ml Urine Meter Foley Tray with Bard EZ-Lok® Sampling Port
Published
2016-06-13
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
KNXCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Product Code Classifications

CodeDeviceSpecialtyClass
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741029124PackageGS110In Commercial Distribution
00801741029127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174102912410801741029124
00801741029127008017410291278017410291270801741029127

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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10801741122122Bard® Robinson Catheter003742000374202016-07-23
10801741122139Bard® Robinson Catheter003744000374402016-07-23
10801741122146Bard® Robinson Catheter003746000374602016-07-23
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