B.I.G.

GUDID 17290008325032

The Adult B.I.G. device is indicated to provide intraosseous access into the proximal tibia and proximal humeral head in adult patients older than 12

WaisMed Ltd

Intraosseous infusion kit

• Primary Device ID: 17290008325032
• NIH Device Record Key: de6b816c-e2a1-46a7-a86c-99d086f6e4c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B.I.G.
• Version Model Number: B.I.G.- A
• Company DUNS: 514619238
• Company Name: WaisMed Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-737-7978
• Email: info@ps-med.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290008325035 [Primary]
GS1	17290008325032 [Package]; Contains: 07290008325035; Package: Carton Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062940

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-12

On-Brand Devices [B.I.G.]

• 17290008325049: The Pediatric B.I.G. device is indicated to provide intraosseous access into the proximal tibia
• 17290008325032: The Adult B.I.G. device is indicated to provide intraosseous access into the proximal tibia and