22G Open-System Ally Blood Collection Device

GUDID 00850042365014

Avia Vascular, LLC

Blood collection set, noninvasive
Primary Device ID00850042365014
NIH Device Record Key52655fc5-2987-41d9-bf75-0b640ee7802d
Commercial Distribution StatusIn Commercial Distribution
Brand Name22G Open-System Ally Blood Collection Device
Version Model NumberAV110000
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

Customer Support Contacts

Phone8017469453
Emailmpell@avia-vascular.com
Phone8017469453
Emailmpell@avia-vascular.com
Phone8017469453
Emailmpell@avia-vascular.com
Phone8017469453
Emailmpell@avia-vascular.com
Phone8017469453
Emailmpell@avia-vascular.com
Phone8017469453
Emailmpell@avia-vascular.com
Phone8017469453
Emailmpell@avia-vascular.com
Phone8017469453
Emailmpell@avia-vascular.com
Phone8017469453
Emailmpell@avia-vascular.com
Phone8017469453
Emailmpell@avia-vascular.com
Phone8017469453
Emailmpell@avia-vascular.com
Phone8017469453
Emailmpell@avia-vascular.com
Phone8017469453
Emailmpell@avia-vascular.com
Phone8017469453
Emailmpell@avia-vascular.com
Phone8017469453
Emailmpell@avia-vascular.com

Device Dimensions

Outer Diameter0.0214 Inch
Outer Diameter0.0214 Inch
Outer Diameter0.0214 Inch
Outer Diameter0.0214 Inch
Outer Diameter0.0214 Inch
Outer Diameter0.0214 Inch
Outer Diameter0.0214 Inch
Outer Diameter0.0214 Inch
Outer Diameter0.0214 Inch
Outer Diameter0.0214 Inch
Outer Diameter0.0214 Inch
Outer Diameter0.0214 Inch
Outer Diameter0.0214 Inch
Outer Diameter0.0214 Inch
Outer Diameter0.0214 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100850042365014 [Primary]
GS110850042365011 [Package]
Package: Inner Pack [8 Units]
In Commercial Distribution
GS120850042365018 [Package]
Contains: 10850042365011
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
00850042365014 - 22G Open-System Ally Blood Collection Device2022-11-01
00850042365014 - 22G Open-System Ally Blood Collection Device2022-11-01

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