FDA.reportPublic FDA data

Port Access Kit

Primary DI
10801741044318
Brand
Port Access Kit
Company
Bard Access Systems, Inc.
Model
2142215
Catalog number
2142215
Device description
PowerLoc MAX 22G x 1.5" 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
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741044318PackageGS15In Commercial Distribution
00801741044311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174104431810801741044318
00801741044311008017410443118017410443110801741044311

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
Length1.5Inch

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810110920207IMed ProductsASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETIFPA2026-03-23
10810110920214IMed ProductsASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETIFPA2026-03-23
10810110920221IMed ProductsASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETIFPA2026-03-23
28699443581373FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETIFPA2026-03-13
28699443583261NeutrArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETIFPA2026-03-13
00850050080367iLet Insulin Infusion KitBeta Bionics, Inc.FPA2026-03-11
10801741239271MiniLocBard Access Systems, Inc.FPA2026-02-26
00850033629439Acta MedicalActa Medical LLCFPA2026-02-26
00850033629583Acta MedicalActa Medical LLCFPA2026-02-26
00850033629590Acta MedicalActa Medical LLCFPA2026-02-26
00813153027899CodanCodan US CorporationFPA2026-02-25
28699443582158NeutrArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETIFPA2026-02-16
00813153028124FRESENIUS KABICodan US CorporationFPA2026-02-05
00813153028131FRESENIUS KABICodan US CorporationFPA2026-02-05
00813153028148FRESENIUS KABICodan US CorporationFPA2026-02-05
00813153028155FRESENIUS KABICodan US CorporationFPA2026-02-05
B2125720502Male Luer Slip PlugINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700B2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700G2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700R2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700V2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700W2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700Y2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
00813153028179CodanCodan US CorporationFPA2026-01-21
10801741239189PowerLocBard Access Systems, Inc.FPA2026-01-20
10801741239196MiniLocBard Access Systems, Inc.FPA2026-01-20
10801741239202MiniLocBard Access Systems, Inc.FPA2026-01-20
10817708023418OPTFlowEMED TECHNOLOGIES CORPORATIONFPA2026-01-09
23661657080947NEUTRACLEAR BIDIRECTIONAL VALVE WITH PROTECTIVE CAPCAIR LGLFPA2026-01-01
2366165708095413,5 CM PE/PVC EXTENSION TUBING WITH 1 NEUTRACLEAR + 1 CLAMP + 1 MOBILE RINGCAIR LGLFPA2026-01-01