FDA.reportPublic FDA data

Port Access Kit

Primary DI
10801741044424
Brand
Port Access Kit
Company
Bard Access Systems, Inc.
Model
2651910
Catalog number
2651910
Device description
PowerLoc 19G x 1" PAK
Published
2016-01-18
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

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
10801741044424PackageGS15In Commercial Distribution
00801741044427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174104442410801741044424
00801741044427008017410444278017410444270801741044427

GMDN Terms#

Term, Definition table
TermDefinition
Vascular port administration setA collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge19Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801741082983StatLockS04020010S040200102025-05-02
10801741087582StatLockD05000002AD05000002A2025-05-02
10801741188852StatLockSEC2404320SEC24043202020-04-22
10801741188869StatLockSEC2404321SEC24043212020-04-22
00801741075452SecurisSEC0100SEC01002019-10-17
00801741081248StatLock068400047206840004722025-05-02
00801741081255StatLock068400049306840004932025-05-02
00801741081521STATLOCKCV0223CV02232023-11-09
00801741081552STATLOCKCV0226CV02262023-11-09
00801741081576STATLOCKCV0321CV03212023-11-09
00801741081675STATLOCKIB0200IB02002023-11-09
00801741081682STATLOCKIV0220IV02202023-11-09
00801741081750STATLOCKIV0500IV05002023-11-09
00801741081767STATLOCKIV0501IV05012023-11-09
00801741081897STATLOCKIV0528IV05282023-11-09
00801741082078STATLOCKIV0568IV05682023-11-09
00801741082085STATLOCKIV0569IV05692023-11-09
00801741082092STATLOCKIV0570IV05702023-11-09
00801741082139STATLOCKIV0577IV05772023-11-09
00801741082153STATLOCKIV0579IV05792023-11-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00849884007466VYGONVygon CorporationLJT2026-05-22
13661234027450PEROUSE MEDICALPEROUSE MEDICALLJT2026-01-22
13661234027467PEROUSE MEDICALPEROUSE MEDICALLJT2026-01-22
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
15051684016858BioFlo VortexAngiodynamics, Inc.LJT2024-11-19
15051684016865BioFlo VortexAngiodynamics, Inc.LJT2024-11-19
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15051684016643BioFlo VortexAngiodynamics, Inc.LJT2024-11-19
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15051684016650BioFlo VortexAngiodynamics, Inc.LJT2024-11-19
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15051684016988BioFlo VortexAngiodynamics, Inc.LJT2024-11-19
15051684016957BioFlo VortexAngiodynamics, Inc.LJT2024-11-19
15051684016964BioFlo VortexAngiodynamics, Inc.LJT2024-11-19
15051684017077BioFlo VortexAngiodynamics, Inc.LJT2024-11-19
15051684016667BioFlo VortexAngiodynamics, Inc.LJT2024-11-19
15051684017060BioFlo VortexAngiodynamics, Inc.LJT2024-11-19
15051684016674BioFlo VortexAngiodynamics, Inc.LJT2024-11-19
15051684016834BioFlo VortexAngiodynamics, Inc.LJT2024-11-19
15051684016841BioFlo VortexAngiodynamics, Inc.LJT2024-11-19
15051684017138BioFlo VortexAngiodynamics, Inc.LJT2024-11-19
15051684016681BioFlo VortexAngiodynamics, Inc.LJT2024-11-19
15051684017121BioFlo VortexAngiodynamics, Inc.LJT2024-11-19