NIO

GUDID 17290008325056

The NIO-A device is indicated to provide intraosseous access into the proximal tibia and proximal humeral head, in adult patients older than 12 years.

WaisMed Ltd

Intraosseous infusion kit
Primary Device ID17290008325056
NIH Device Record Keyea3c1d2d-499c-481e-9d65-e998b3d9edba
Commercial Distribution StatusIn Commercial Distribution
Brand NameNIO
Version Model NumberNIO-A
Company DUNS514619238
Company NameWaisMed Ltd
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-737-7978
Emailinfo@ps-med.com
Phone1-888-737-7978
Emailinfo@ps-med.com
Phone1-888-737-7978
Emailinfo@ps-med.com
Phone1-888-737-7978
Emailinfo@ps-med.com
Phone1-888-737-7978
Emailinfo@ps-med.com
Phone1-888-737-7978
Emailinfo@ps-med.com
Phone1-888-737-7978
Emailinfo@ps-med.com
Phone1-888-737-7978
Emailinfo@ps-med.com
Phone1-888-737-7978
Emailinfo@ps-med.com
Phone1-888-737-7978
Emailinfo@ps-med.com
Phone1-888-737-7978
Emailinfo@ps-med.com
Phone1-888-737-7978
Emailinfo@ps-med.com
Phone1-888-737-7978
Emailinfo@ps-med.com
Phone1-888-737-7978
Emailinfo@ps-med.com
Phone1-888-737-7978
Emailinfo@ps-med.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290008325059 [Primary]
GS117290008325056 [Package]
Contains: 07290008325059
Package: Carton Box [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-12

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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