NIO Fixation

GUDID 07290008325097

WaisMed Ltd

First aid gauze/bandage
Primary Device ID07290008325097
NIH Device Record Keya35a9025-c2f8-48ea-93c3-5689a0653507
Commercial Distribution StatusIn Commercial Distribution
Brand NameNIO Fixation
Version Model NumberNIO Fixation
Company DUNS514619238
Company NameWaisMed Ltd
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290008325097 [Primary]

FDA Product Code

KMKDevice, Intravascular Catheter Securement

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

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

Devices Manufactured by WaisMed Ltd

27290008325107 - GOIO2021-04-14 Intraosseous start kit by PerSys Medical
07290008325080 - NIO2020-08-18 The NIO Pediatric device is indicated to provide intraosseous access in the proximal tibia as an alternative to IV access during
07290008325097 - NIO Fixation2020-08-18
07290008325097 - NIO Fixation2020-08-18
07290008325066 - NIO2019-11-19 The NIO-Infant (NIO-I) is an intraosseous device intended to provide vascular access in the proximal tibia of infants as an alte
17290008325025 - NIO2018-07-06 The Pediatric NIO device is indicated to provide intraosseous access in the proximal tibia as an alternative to IV access during
17290008325032 - B.I.G.2018-07-06 The Adult B.I.G. device is indicated to provide intraosseous access into the proximal tibia and proximal humeral head in adult p
17290008325049 - B.I.G.2018-07-06 The Pediatric B.I.G. device is indicated to provide intraosseous access into the proximal tibia on children from 0-12 years of a
17290008325056 - NIO2018-07-06 The NIO-A device is indicated to provide intraosseous access into the proximal tibia and proximal humeral head, in adult patient

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