NIO

GUDID 07290008325080

The NIO Pediatric device is indicated to provide intraosseous access in the proximal tibia as an alternative to IV access during emergencies. The device is for use in pediatric patients up to 12 years of age. New stabilizer for the pediatric device

WaisMed Ltd

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Primary Device ID07290008325080
NIH Device Record Keya116d3f0-b097-4dfc-9afd-61eb46e3eb2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNIO
Version Model NumberNIO-P
Company DUNS514619238
Company NameWaisMed Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Phone1-888-737-7978
Emailinfo@persysmedical.com
Phone1-888-737-7978
Emailinfo@persysmedical.com
Phone1-888-737-7978
Emailinfo@persysmedical.com
Phone1-888-737-7978
Emailinfo@persysmedical.com
Phone1-888-737-7978
Emailinfo@persysmedical.com
Phone1-888-737-7978
Emailinfo@persysmedical.com
Phone1-888-737-7978
Emailinfo@persysmedical.com
Phone1-888-737-7978
Emailinfo@persysmedical.com
Phone1-888-737-7978
Emailinfo@persysmedical.com
Phone1-888-737-7978
Emailinfo@persysmedical.com
Phone1-888-737-7978
Emailinfo@persysmedical.com
Phone1-888-737-7978
Emailinfo@persysmedical.com
Phone1-888-737-7978
Emailinfo@persysmedical.com
Phone1-888-737-7978
Emailinfo@persysmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290008325080 [Primary]
GS117290008325087 [Package]
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-18
Device Publish Date2020-08-10

On-Brand Devices [NIO]

17290008325056The NIO-A device is indicated to provide intraosseous access into the proximal tibia and proxima
17290008325025The Pediatric NIO device is indicated to provide intraosseous access in the proximal tibia as an
07290008325066The NIO-Infant (NIO-I) is an intraosseous device intended to provide vascular access in the prox
07290008325080The NIO Pediatric device is indicated to provide intraosseous access in the proximal tibia as an
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