AllPoints Port Access System PowerLoc Max AN132075B

GUDID 10801741215213

AllPoints Port Access System PowerLoc Max 20G x 0.75 inch with Y-Site + BioPatch

Bard Access Systems, Inc.

Vascular port administration set
Primary Device ID10801741215213
NIH Device Record Keye437c498-808a-4bee-bc8a-485a23484091
Commercial Distribution StatusIn Commercial Distribution
Brand NameAllPoints Port Access System PowerLoc Max
Version Model NumberAN132075B
Catalog NumberAN132075B
Company DUNS044611812
Company NameBard Access Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com

Device Dimensions

Length0.75 Inch
Needle Gauge20 Gauge
Length0.75 Inch
Needle Gauge20 Gauge
Length0.75 Inch
Needle Gauge20 Gauge
Length0.75 Inch
Needle Gauge20 Gauge
Length0.75 Inch
Needle Gauge20 Gauge
Length0.75 Inch
Needle Gauge20 Gauge
Length0.75 Inch
Needle Gauge20 Gauge
Length0.75 Inch
Needle Gauge20 Gauge
Length0.75 Inch
Needle Gauge20 Gauge
Length0.75 Inch
Needle Gauge20 Gauge
Length0.75 Inch
Needle Gauge20 Gauge
Length0.75 Inch
Needle Gauge20 Gauge
Length0.75 Inch
Needle Gauge20 Gauge
Length0.75 Inch
Needle Gauge20 Gauge
Length0.75 Inch
Needle Gauge20 Gauge

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741215216 [Primary]
GS110801741215213 [Package]
Contains: 00801741215216
Package: CA [10 Units]
In Commercial Distribution

FDA Product Code

PTINon-coring (Huber) needle

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-29
Device Publish Date2020-09-21

On-Brand Devices [AllPoints Port Access System PowerLoc Max]

10801741215312AllPoints Port Access System PowerLoc Max 20G x 1 inch with Y-Site + BioPatch
10801741215220AllPoints Port Access System PowerLoc Max 20G x 1 inch + BioPatch
10801741215213AllPoints Port Access System PowerLoc Max 20G x 0.75 inch with Y-Site + BioPatch
10801741215206AllPoints Port Access System PowerLoc Max 20G x 0.75 inch + BioPatch
10801741119313AllPoints Port Access System PowerLoc Max 20G x 0.75 inch + GuardIVa
10801741119061AllPoints Port Access System PowerLoc Max 20G x 1 inch with Y-Site + GuardIVa
10801741118972AllPoints Port Access System PowerLoc Max 20G x 1 inch with Y-Site
10801741119054AllPoints Port Access System PowerLoc Max 20G x 0.75 inch with Y-Site + GuardIVa
10801741232395AllPoints Port Access System PowerLoc Max 20G x 1 inch
10801741232371AllPoints Port Access System PowerLoc Max 20G x 0.75 inch
10801741232364AllPoints Port Access System PowerLoc Max 20G x 1 inch with Y-Site
10801741232357AllPoints Port Access System PowerLoc Max 20G x 0.75 inch with Y-Site

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.