20G Open-System Ally Blood Collection Device

GUDID 00850042365007

Avia Vascular, LLC

Blood collection set, noninvasive
Primary Device ID00850042365007
NIH Device Record Key80eb8b2f-f89a-446b-b111-a8d1f8e3e584
Commercial Distribution StatusIn Commercial Distribution
Brand Name20G Open-System Ally Blood Collection Device
Version Model NumberAV100000
Company DUNS106772781
Company NameAvia Vascular, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
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

Device Dimensions

Outer Diameter0.0274 Inch
Outer Diameter0.0274 Inch
Outer Diameter0.0274 Inch
Outer Diameter0.0274 Inch
Outer Diameter0.0274 Inch
Outer Diameter0.0274 Inch
Outer Diameter0.0274 Inch
Outer Diameter0.0274 Inch
Outer Diameter0.0274 Inch
Outer Diameter0.0274 Inch
Outer Diameter0.0274 Inch
Outer Diameter0.0274 Inch
Outer Diameter0.0274 Inch
Outer Diameter0.0274 Inch
Outer Diameter0.0274 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100850042365007 [Primary]
GS110850042365004 [Package]
Package: Inner Pack [8 Units]
In Commercial Distribution
GS120850042365001 [Package]
Contains: 10850042365004
Package: Case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JKATubes, Vials, Systems, Serum Separators, Blood Collection

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-01
Device Publish Date2022-10-24

Devices Manufactured by Avia Vascular, LLC

10850042365059 - 20G 8CM Stiletto Extended Dwell Catheter2024-07-03 The Stiletto Extended Dwell Catheter (EDC) is a sterile, single use device designed to allow users to sample blood and/or admini
00850042365007 - 20G Open-System Ally Blood Collection Device2022-11-01
00850042365007 - 20G Open-System Ally Blood Collection Device2022-11-01
00850042365014 - 22G Open-System Ally Blood Collection Device2022-11-01

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