B.I.G.

GUDID 17290008325049

The Pediatric B.I.G. device is indicated to provide intraosseous access into the proximal tibia on children from 0-12 years of age.

WaisMed Ltd

Intraosseous infusion kit

• Primary Device ID: 17290008325049
• NIH Device Record Key: 55ce2d98-f339-4975-954a-002658d53a23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B.I.G.
• Version Model Number: B.I.G.- P
• 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	07290008325042 [Primary]
GS1	17290008325049 [Package]; Contains: 07290008325042; Package: Carton Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022415

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