PowerPICC SOLO Provena CK001083

GUDID 10801741234498

Catheter Placement Kit (PICCs)

Bard Access Systems, Inc.

Peripherally-inserted central venous catheter
Primary Device ID10801741234498
NIH Device Record Key11cdf611-5a2b-4bb9-92e0-5511777c100d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowerPICC SOLO Provena
Version Model NumberCK001083
Catalog NumberCK001083
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

Device Dimensions

Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741234491 [Primary]
GS110801741234498 [Package]
Contains: 00801741234491
Package: CA [3 Units]
In Commercial Distribution

FDA Product Code

LJSCatheter, intravascular, therapeutic, long-term greater 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 Date2024-12-17
Device Publish Date2024-12-09

On-Brand Devices [PowerPICC SOLO Provena]

10801741231718Catheter Placement Kit
10801741231701Catheter Placement Kit
10801741231565Catheter Placement Kit
10801741234627Catheter Placement Kit (PICCs)
10801741234610Catheter Placement Kit (PICCs)
10801741234498Catheter Placement Kit (PICCs)
10801741234474Catheter Placement Kit (PICCs)

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