Multi-Sample Blood Collection Set MER2021

GUDID 16958697602971

A sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient. It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike however it does not include a blood collection tube holder. This is a single-use device.

ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD

Blood collection set, invasive

• Primary Device ID: 16958697602971
• NIH Device Record Key: be7064a3-2dc2-4eeb-b5a4-3a8b01c15013
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multi-Sample Blood Collection Set
• Version Model Number: 21G x 3/4"
• Catalog Number: MER2021
• Company DUNS: 543007373
• Company Name: ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06958697602974 [Primary]
GS1	16958697602971 [Package]; Contains: 06958697602974; Package: [50 Units]; In Commercial Distribution
GS1	26958697602978 [Package]; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202188

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-09
• Device Publish Date: 2021-07-31

On-Brand Devices [Multi-Sample Blood Collection Set]

• 16958697602971: A sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood coll
• 16958697607228: A sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood coll
• 16958697607211: A sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood coll