FDA.reportPublic FDA data

Port Access Kit

Primary DI
10801741085540
Brand
Port Access Kit
Company
Bard Access Systems, Inc.
Model
PA-0032
Catalog number
PA-0032
Device description
Port Access Kit SafeStep 20G x 1 inch
Published
2016-09-20
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
10801741085540PackageGS15In Commercial Distribution
00801741085543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174108554010801741085540
00801741085543008017410855438017410855430801741085543

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 Gauge20Gauge

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
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08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
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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
08498840010730Churchill Medical SystemsVygon CorporationFPA2020-05-21
08498840009338VYGONVygon CorporationFPA2020-04-21
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08498840006535VYGONVygon CorporationFPA2020-03-12
08498840011638VYGONVygon CorporationFPA2020-03-12
08498840010518Churchill Medical SystemsVygon CorporationFPA2019-05-20
08498840010525Churchill Medical SystemsVygon CorporationFPA2019-05-20
08498840010532Churchill Medical SystemsVygon CorporationFPA2019-05-20
08498840010549Churchill Medical SystemsVygon CorporationFPA2019-05-20
08498840012239VYGONVygon CorporationFPA2019-04-17
08498840000014VYGONVygon CorporationFPA2017-07-28
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08498840010884VYGONVygon CorporationFPA2017-07-28
08498840010891VYGONVygon CorporationFPA2017-07-28
08498840010907VYGONVygon CorporationFPA2017-07-28