Vacuflow™ MED 5021

GUDID 00850011007006

Butterfly, Vacuflow non-safety, w/adapter 21G 12" tubing 50/bx

MERCEDES MEDICAL, LLC

Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set

• Primary Device ID: 00850011007006
• NIH Device Record Key: 990bfd8b-437f-4b57-843e-ffd9c535ffeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vacuflow™
• Version Model Number: MED 5021
• Catalog Number: MED 5021
• Company DUNS: 834472680
• Company Name: MERCEDES MEDICAL, LLC
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011007006 [Primary]
GS1	10850011007003 [Package]; Package: Inner Pack [50 Units]; In Commercial Distribution
GS1	20850011007000 [Package]; Contains: 10850011007003; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000714

FDA Product Code

• JKA: Tubes, Vials, Systems, Serum Separators, Blood Collection

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-08-15

On-Brand Devices [Vacuflow™]

• 00850011007211: Butterfly Safety Luer Adapter 25g; 50bx
• 20850011007208: Vacuflow Butterfly Safety Luer Adapter 23g; 50bx
• 00850011007198: Vacuflow Butterfly Safety Luer Adapter 21g; 50bx
• 00850011007181: Butterfly, Vacuflow non-safety, w/adapter 25G 12" tubing 50/bx
• 20850011007055: Butterfly, Vacuflow non-safety, w/adapter 23G 12" tubing 50/bx
• 00850011007006: Butterfly, Vacuflow non-safety, w/adapter 21G 12" tubing 50/bx