PowerGlide Pro PCK00012

GUDID 10801741224567

Catheter Placement Kit

Bard Access Systems, Inc.

Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter
Primary Device ID10801741224567
NIH Device Record Keyc7e86577-1054-488a-b656-87b3e9fabc03
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowerGlide Pro
Version Model NumberPCK00012
Catalog NumberPCK00012
Company DUNS044611812
Company NameBard Access Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
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

Length10 Centimeter
Device Size Text, specify0
Length10 Centimeter
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Length10 Centimeter
Device Size Text, specify0
Length10 Centimeter
Device Size Text, specify0
Length10 Centimeter
Device Size Text, specify0
Length10 Centimeter
Device Size Text, specify0
Length10 Centimeter
Device Size Text, specify0
Length10 Centimeter
Device Size Text, specify0
Length10 Centimeter
Device Size Text, specify0
Length10 Centimeter
Device Size Text, specify0
Length10 Centimeter
Device Size Text, specify0
Length10 Centimeter
Device Size Text, specify0
Length10 Centimeter
Device Size Text, specify0
Length10 Centimeter
Device Size Text, specify0
Length10 Centimeter
Device Size Text, specify0
Length10 Centimeter
Device Size Text, specify0
Length10 Centimeter
Device Size Text, specify0
Length10 Centimeter
Device Size Text, specify0
Length10 Centimeter
Device Size Text, specify0
Length10 Centimeter
Device Size Text, specify0
Length10 Centimeter
Device Size Text, specify0
Length10 Centimeter
Device Size Text, specify0

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
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
GS100801741224560 [Primary]
GS110801741224567 [Package]
Contains: 00801741224560
Package: CA [6 Units]
In Commercial Distribution

FDA Product Code

FOZCatheter, intravascular, therapeutic, short-term less than 30 days

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-04
Device Publish Date2022-02-24

On-Brand Devices [PowerGlide Pro]

10801741152921DOT PG Pro 22G 8cm RT Max W/NG
10801741152914DOT PG Pro 20G 10cm RT Max W/NG
10801741152907DOT PG Pro 20G 8cm RT Max W/NG
10801741152891DOT PG Pro 18G 10cm RT Max W/NG
10801741152884DOT PG Pro 18G 8cm RT Max W/NG
10801741152877PG Pro 22G 8cm RT Full W/NG
10801741152860PG Pro 20G 10cm RT Full W/NG
10801741152853PG Pro 20G 8cm RT Full W/NG
10801741152846PG Pro 18G 10cm RT Full W/NG
10801741152839PG Pro 18G 8cm RT Full W/NG
10801741152822PG Pro 22G 8cm RT Full w/GIva&NG
10801741152815PG Pro 20G 10cm RT Full w/GIva&NG
10801741152808PG Pro 20G 8cm RT Full w/GIva&NG
10801741152792PG Pro 18G 10cm RT Full w/GIva&NG
10801741152785PG Pro 18G 8cm RT Full w/GIva&NG
10801741152778DOT PG Pro 22G 8cm RT Full B&P w/NG
10801741152761DOT PG Pro 20G10cm RT Full B&P w/NG
10801741152754DOT PG Pro 20G 8cm RT Full B&P w/NG
10801741152747DOT PG Pro 18G10cm RT Full B&P w/NG
10801741152730DOT PG Pro 18G 8cm RT Full B&P w/NG
10801741152723DOT PG Pro 22G 8cm RT Full PCover w/NG
10801741152709DOT PG Pro 20G10cm RT Full PCover w/NG
10801741152693DOT PG Pro 20G 8cm RT Full PCover w/NG
10801741152686DOT PG Pro 18G10cm RT Full PCover w/NG
10801741152679DOT PG Pro 18G 8cm RT Full PCover w/NG
10801741152662DOT PG Pro 22G 8cm RT Full G&P w/NG
10801741152655DOT PG Pro 20G10cm RT Full G&P w/NG
10801741152648DOT PG Pro 20G 8cm RT Full G&P w/NG
10801741152556DOT PG Pro 18G10cm RT Full G&P w/NG
10801741152549DOT PG Pro 18G 8cm RT Full G&P w/NG
10801741152532DOT PG Pro 22G 8cm RT Full BioPatch w/NG
10801741152525DOT PG Pro 20G10cm RT Full BioPatch w/NG
10801741152518DOT PG Pro 20G 8cm RT Full BioPatch w/NG
10801741152501DOT PG Pro 18G10cm RT Full BioPatch w/NG
10801741152495DOT PG Pro 18G 8cm RT Full BioPatch w/NG
10801741152488PG Pro 22G 8cm RT Basic W/NG
20801741152478PG Pro 20G 10cm RT Basic W/NG
20801741152461PG Pro 20G 8cm RT Basic W/NG
20801741152454PG Pro 18G 10cm RT Basic W/NG
20801741152447PG Pro 18G 8cm RT Basic W/NG
20801741152430PG Pro 22G 8cm RT Basic w/GIva&NG
20801741152423PG Pro 20G10cm RT Basic w/GIva&NG
10801741152419PG Pro 20G 8cm RT Basic w/GIva&NG
20801741152409PG Pro 18G10cm RT Basic w/GIva&NG
20801741152393PG Pro 18G 8cm RT Basic w/GIva&NG
10801741152389PG Pro 22G 8cm RT Basic BioPatch w/NG
10801741152372PG Pro 20G10cm RT Basic BioPatch w/NG
20801741152362PG Pro 20G 8cm RT Basic BioPatch w/NG
10801741152358PG Pro 18G10cm RT Basic BioPatch w/NG
10801741152341PG Pro 18G 8cm RT Basic BioPatch w/NG

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