UNOLOK 00326

GUDID 08903347003265

UNOLOK Luer Lock Infusion Set,21 G X ¾" ( 0.80X19MM) 12" TUBE MYCO RE-ORDER # 7001-21

HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED

Venous butterfly needle/set

• Primary Device ID: 08903347003265
• NIH Device Record Key: 19f0c502-6cce-41c6-baea-5191f64d658e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNOLOK
• Version Model Number: 21 G X ¾"
• Catalog Number: 00326
• 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	08903347003265 [Primary]
GS1	18903347003262 [Package]; Package: BOX [100 Units]; In Commercial Distribution
GS1	28903347003269 [Package]; Contains: 18903347003262; Package: CARTON [10 Units]; In Commercial Distribution
GS1	58903347003260 [Package]; Contains: 28903347003269; Package: PALLET [18 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953252

FDA Product Code

• FOZ: Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

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: 2017-04-26

On-Brand Devices [UNOLOK ]

• 08903347003302: UNOLOK Luer Lock Infusion Sets,25 G X ¾" ( 0.50X19MM) 12" TUBE MYCO RE-ORDER # 7001-25
• 08903347003289: UNOLOK Luer Lock Infusion Sets,23 G X ¾" (0.60 X19MM ) 12" TUBE MYCO RE-ORDER # 7001-23
• 08903347003272: UNOLOK Luer Lock Infusion Set,22 G X ¾" ( 0.70X19MM) 12" TUBE MYCO RE-ORDER # 7001-22
• 08903347003265: UNOLOK Luer Lock Infusion Set,21 G X ¾" ( 0.80X19MM) 12" TUBE MYCO RE-ORDER # 7001-21
• 08903347003241: UNOLOK Luer Lock Infusion Set,19 G X ¾" ( 1.10X19MM) 12" TUBE MYCO RE-ORDER # 7001-19
• 18903347051898: UNOLOK Single Use Hypodermic Syringe Luer Lock , 3ml with 22G x 1 1/2'' (0.70 X 38mm) Needle, B