Blood Collection Set

GUDID 00616784895024

DYNAREX CORPORATION

Blood collection needle Blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle

• Primary Device ID: 00616784895024
• NIH Device Record Key: 2f734c76-0af3-46dc-822d-23b3012120df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blood Collection Set
• Version Model Number: 8950
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784895024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151991

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-01-08
• Device Publish Date: 2018-08-06

On-Brand Devices [Blood Collection Set]

• 00616784895222: 8952
• 00616784895123: 8951
• 00616784895024: 8950