PowerFlow IV Port Access AIV16

GUDID 20801741136645

PowerFlow IV Port Access System, 16G

Bard Access Systems, Inc.

Apheresis kit Apheresis kit
Primary Device ID20801741136645
NIH Device Record Keyda257840-1dbd-42b1-8072-d6fa5a2e3a7d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowerFlow IV Port Access
Version Model NumberAIV16
Catalog NumberAIV16
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

Device Dimensions

Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741136641 [Primary]
GS110801741136648 [Package]
Contains: 00801741136641
Package: CA [5 Units]
In Commercial Distribution
GS120801741136645 [Package]
Contains: 10801741136648
Package: BX [2 Units]
In Commercial Distribution

FDA Product Code

PTDSubcutaneous implanted apheresis port

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-07-05

On-Brand Devices [PowerFlow IV Port Access]

20801741136645PowerFlow IV Port Access System, 16G
10801741136631PowerFlow IV Port Access System, 14G

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.