FDA.reportPublic FDA data

PowerLoc

Primary DI
00801741199783
Brand
PowerLoc
Company
Bard Access Systems, Inc.
Model
CPA00060
Catalog number
CPA00060
Device description
Port Access Kit
Published
2019-11-26
Public version status
New
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
FPASet, administration, intravascular
LJTPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741199780PackageGS15In Commercial Distribution
00801741199783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174119978010801741199780
00801741199783008017411997838017411997830801741199783

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
Length0.75Inch
Needle Gauge20Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
044611812
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741240034PowerPICC SOLOCK001093CK0010932026-05-27
00801741240041PowerPICC Provena SOLOCK001094CK0010942026-05-27
00801741240058PowerPICC Provena SOLOCK001095CK0010952026-05-27
00801741240065PowerPICC Provena SOLO Catheter with Sherlock 3CGCK001096CK0010962026-05-27
00801741240072PowerPICC Provena SOLO Catheter with Sherlock 3CGCK001097CK0010972026-05-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
07640110985465Tita Jet Light PFM MEDICAL INCORPORATEDLJT2020-02-27
07640110985472Tita Jet LightPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110985489Jet Port PlusPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110985496T-Port PFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987247T-PortPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987254T-PortPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987476T-PortPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987506Jet Port PlusPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987513Tita Jet LightPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987537T-Port PFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987643Jet Port PlusPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987704Low Profile PeripheralPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987728Low Profile PeripheralPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987742Low Profile PeripheralPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987940Jet Port Plus IIPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110987988Tita Jet Light IIPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110988336T-PortPFM MEDICAL INCORPORATEDLJT2020-02-27
07640110988350T-PortPFM MEDICAL INCORPORATEDLJT2020-02-27