Vaku-8 02347

GUDID 18903347023475

VAKU-8 Blood Collection Set, 25G X ¾" (0.50X19MM) 12" TUBE MYCO REORDER # SVMS-25A

HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED

Venous butterfly needle/set

• Primary Device ID: 18903347023475
• NIH Device Record Key: c32912e9-7183-4fb2-9d68-13deac0f04fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vaku-8
• Version Model Number: 25 G X ¾"
• Catalog Number: 02347
• Company DUNS: 862318107
• Company Name: HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08903347023478 [Primary]
GS1	18903347023475 [Package]; Contains: 08903347023478; Package: BOX [100 Units]; In Commercial Distribution
GS1	28903347023472 [Package]; Package: Carton [10 Units]; In Commercial Distribution
GS1	58903347023473 [Package]; Contains: 28903347023472; Package: Palet [18 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000592

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: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-01-09

On-Brand Devices [Vaku-8]

• 08903347034696: VAKU-8 Blood Collection Set,22 G X 3/4" ( 0.70X19MM) 12" TUBE MYCO RE-ORDER # SVMS-22A
• 18903347023475: VAKU-8 Blood Collection Set, 25G X ¾" (0.50X19MM) 12" TUBE MYCO REORDER # SVMS-25A
• 18903347023468: VAKU-8 Blood Collection Set,23G X ¾" ( 0.60 X 19MM ) 12" TUBE MYCO RE-ORDER # SVMS-23A
• 08903347023454: VAKU-8 Blood Collection Set,21 G X ¾" (0.80X19MM ) 12" TUBE MYCO RE-ORDER # SVMS-21A