Halsted Health

GUDID 00860006105068

Syringes with needle

Flex Source International, Inc.

Medication transfer set

• Primary Device ID: 00860006105068
• NIH Device Record Key: 7f33042c-3dba-4e93-a394-099a83a90a8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Halsted Health
• Version Model Number: Part Number: 2523
• Company DUNS: 097915269
• Company Name: Flex Source International, Inc.
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com
• Phone: 858-539-6246
• Email: info@halstedhealth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006105044 [Primary]
GS1	00860006105068 [Package]; Contains: 00860006105044; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112057

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-18
• Device Publish Date: 2021-02-10

On-Brand Devices [Halsted Health]

• 00860006105020: Syringes with needle
• 00860006105068: Syringes with needle
• 00860006105099: Silicone Male External Catheter. Self-Adhering. Non-Sterile.
• 00860006105051: Silicone Male External Catheter. Self-Adhering. Non-Sterile.
• 00860010400227: BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE