NIO Fixation

GUDID 07290008325097

WaisMed Ltd

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• Primary Device ID: 07290008325097
• NIH Device Record Key: a35a9025-c2f8-48ea-93c3-5689a0653507
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIO Fixation
• Version Model Number: NIO Fixation
• Company DUNS: 514619238
• Company Name: WaisMed Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290008325097 [Primary]

FDA Product Code

• KMK: Device, Intravascular Catheter Securement

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-18
• Device Publish Date: 2020-08-10

Devices Manufactured by WaisMed Ltd

• 27290008325107 - GOIO: 2021-04-14 Intraosseous start kit by PerSys Medical
• 07290008325080 - NIO: 2020-08-18 The NIO Pediatric device is indicated to provide intraosseous access in the proximal tibia as an alternative to IV access during
• 07290008325097 - NIO Fixation: 2020-08-18
• 07290008325097 - NIO Fixation: 2020-08-18
• 07290008325066 - NIO: 2019-11-19 The NIO-Infant (NIO-I) is an intraosseous device intended to provide vascular access in the proximal tibia of infants as an alte
• 17290008325025 - NIO: 2018-07-06 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 - NIO: 2018-07-06 The NIO-A device is indicated to provide intraosseous access into the proximal tibia and proximal humeral head, in adult patient