FDA.reportPublic FDA data

Bard® X-Force® Balloon Dilation Catheter

Primary DI
00801741052064
Brand
Bard® X-Force® Balloon Dilation Catheter
Company
C. R. Bard, Inc.
Model
997504
Catalog number
997504
Device description
Bard® X-Force® Balloon Dilation Catheter
Published
2016-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZNDILATOR, CATHETER, URETERAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZNDilator, Catheter, UreteralGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741052064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741052064008017410520648017410520640801741052064

GMDN Terms#

Term, Definition table
TermDefinition
Ureteral dilatation catheterA flexible tube designed to be inserted into the ureters exclusively to increase the ureteral lumen by eliminating areas of narrowing (i.e., strictures). It is typically made of plastic and may have a special tip (e.g., olive) or an inflatable hydraulic balloon at its tip for dilating. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Length4Centimeter
Device Size Text, specify0
Length4Centimeter
Outer Diameter5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from heat and radioactive sources

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)526-4455medical.services@crbard.com
+1(844)823-5433BMD.CS.support@bd.com

Regulatory Flags#

DUNS number
016898496
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741050817Leg Bag1505071505072020-09-23
00801741076039Catheter Stabilization DeviceVFDSPVFDSP2020-09-22
00801741076053Catheter Stabilization DeviceVFDSSPVFDSSP2020-09-22
00801741076077Catheter Stabilization DeviceFOL0100FOL01002020-09-22
00801741076091Catheter Stabilization DeviceFOL0101FOL01012020-09-22
00801741076114Catheter Stabilization DeviceFOL0102FOL01022020-09-22
00801741076145Catheter Stabilization DeviceFOL0105FOL01052020-09-22
00801741127625Bard® Leg Bag Holders1501111501112016-08-10
00801741127632Bard® Leg Bag Holders1501211501212016-08-10
00801741127649Bard® Leg Bag Holders1501311501312016-08-10
00801741137419Bard® Wide Leg Bag Straps1621101621102018-02-06
00801741137426Bard® Wide Leg Bag Straps1622101622102018-02-06
00801741137433Bard® Wide Leg Bag Straps1623101623102018-02-06
00801741215902StatLock UrologicalSTATURO25STATURO252020-10-23
00801741231025PureWickPW300PCPW300PC2026-05-07
00801741234514PureWickPWA300HPWA300H2026-05-07
00801741225239Elyra708200170820012026-05-06
00801741225246Elyra708200270820022026-05-06
00801741231537PureWickPWKIT03HPWKIT03H2026-05-06
10801741239219PureWickPWF030KXSPWF030KXS2026-05-05

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Primary DI, Brand, Company table
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03600040911051ColoplastColoplast A/SEZN2024-05-21
03600040911082ColoplastColoplast A/SEZN2024-05-21
03600040953792ColoplastColoplast A/SEZN2024-05-21
03600040911068ColoplastColoplast A/SEZN2024-05-21
03600040911105ColoplastColoplast A/SEZN2024-05-21
03600040953808ColoplastColoplast A/SEZN2024-05-21
03600040953761ColoplastColoplast A/SEZN2024-05-10
03600040953785ColoplastColoplast A/SEZN2024-05-10
03600040953679ColoplastColoplast A/SEZN2024-04-12
03600040953709ColoplastColoplast A/SEZN2024-04-12
03600040953730ColoplastColoplast A/SEZN2024-04-12
03600040953693ColoplastColoplast A/SEZN2024-04-12
03600040953716ColoplastColoplast A/SEZN2024-04-12
03600040953747ColoplastColoplast A/SEZN2024-04-12
00812261012605ARMADAALLWIN MEDICAL DEVICES, INC.EZN2023-07-31
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10812261012602ARMADAALLWIN MEDICAL DEVICES, INC.EZN2023-07-31
10812261012619ARMADAALLWIN MEDICAL DEVICES, INC.EZN2023-07-31
03600040325117Porges ColoplastColoplast A/SEZN2020-06-19
03600040325148Porges ColoplastColoplast A/SEZN2020-06-19
03600040325179Porges ColoplastColoplast A/SEZN2020-06-19
05708932727501Porges ColoplastColoplast A/SEZN2020-06-19
05708932727532Porges ColoplastColoplast A/SEZN2020-06-19
05708932727563Porges ColoplastColoplast A/SEZN2020-06-19
00827002150799Cook 810COOK INCORPORATEDEZN2019-11-26
03600040255728Porges ColoplastColoplast A/SEZN2019-06-30