FDA.reportPublic FDA data

M.R.I. Implantable Port

Primary DI
10801741026185
Brand
M.R.I. Implantable Port
Company
Bard Access Systems, Inc.
Model
0607540
Catalog number
0607540
Device description
X-Port isp M.R.I. Implantable Port with Attachable 8F ChronoFlex Open-Ended Single-Lumen Venous Catheter Intermediate Kit
Published
2015-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LJTPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJTPort & Catheter, Implanted, Subcutaneous, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741026185PackageGS15In Commercial Distribution
00801741026188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174102618510801741026185
00801741026188008017410261888017410261880801741026188

GMDN Terms#

Term, Definition table
TermDefinition
Vascular port/catheterA fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French
Length60Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)545-0890medical.services@crbard.com

Regulatory Flags#

DUNS number
044611812
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741036712Groshong771070077107002015-09-24
00801741036729Groshong771155077115502015-09-24
00801741037696Groshong772495077249502015-09-24
00801741037719Groshong774155077415502015-09-24
10801741239356PowerPICC Sherlock 3CGCK001067ACK001067A2026-03-11
10801741239363PowerPICC ProvenaCK001068ACK001068A2026-03-11
10801741239370PowerPICC ProvenaCK001069ACK001069A2026-03-11
10801741239271MiniLocCPA00072CPA000722026-02-26
10801741238830PowerPICC Provena SOLOCK001091CK0010912026-02-11
00801741038464Niagara Slim-Cath catheter543215054321502015-12-04
00801741038471Niagara Slim-Cath Catheter543220054322002015-11-20
00801741038488Niagara Slim-Cath catheter543224054322402015-12-04
00801741045141Niagara Slim-Cath catheter543412054341202015-11-20
00801741045158Niagara Slim-Cath catheter543415054341502015-11-06
10801741231275CentroVena One1K0R72161K0R72162026-01-23
10801741231282CentroVena One1K0R72201K0R72202026-01-23
10801741231305CentroVena One1K0R73161K0R73162026-01-23
10801741231312CentroVena One1K0R73201K0R73202026-01-23
10801741231329CentroVena One1K0R73301K0R73302026-01-23
10801741231336CentroVena One1MB0R72161MB0R72162026-01-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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13661234027450PEROUSE MEDICALPEROUSE MEDICALLJT2026-01-22
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13661234027474PEROUSE MEDICALPEROUSE MEDICALLJT2026-01-22
13661234027481PEROUSE MEDICALPEROUSE MEDICALLJT2026-01-22
10610586032660ICU Medical, Inc.ICU MEDICAL, INC.LJT2026-01-05
10801741232401AllPoints Port Access System PowerLocBard Access Systems, Inc.LJT2024-12-05
30801741232429AllPoints Port Access System PowerLocBard Access Systems, Inc.LJT2024-12-05
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15051684018777BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018784BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018807XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018821XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018845XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018852XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018869XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018876XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018890XcelaAngiodynamics, Inc.LJT2024-09-20
15051684017985Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018005Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018081Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018098Smart Port CTAngiodynamics, Inc.LJT2024-07-23