UNOLOK+ 00233

GUDID 08903347002336

UNOLOK+ Luer Lock Infusion Set,19 G X ¾" ( 1.10X19MM) 7" TUBE MYCO RE-ORDER # 7001P-19L

HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED

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• Primary Device ID: 08903347002336
• NIH Device Record Key: cba43b95-854c-4401-ab3c-858edba78a41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNOLOK+
• Version Model Number: 19 G X ¾"
• Catalog Number: 00233
• 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	08903347002336 [Primary]
GS1	18903347002333 [Package]; Package: BOX [100 Units]; In Commercial Distribution
GS1	28903347002330 [Package]; Contains: 18903347002333; Package: CARTON [10 Units]; In Commercial Distribution
GS1	58903347002331 [Package]; Contains: 28903347002330; Package: PALLET [14 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: 2017-04-26

On-Brand Devices [UNOLOK+]

• 08903347002367: UNOLOK+ Luer Lock Infusion Set,25 G X ¾" ( 0.50X19MM) 7" TUBE MYCO RE-ORDER # 7001P-25L
• 08903347002350: UNOLOK+ Luer Lock Infusion Set,23 G X ¾" ( 0.60X19MM) 7" TUBE MYCO RE-ORDER # 7001P-23L
• 08903347002343: UNOLOK+ Luer Lock Infusion Set,21 G X ¾" ( 0.80X19MM) 7" TUBE MYCO RE-ORDER # 7001P-21L
• 08903347002336: UNOLOK+ Luer Lock Infusion Set,19 G X ¾" ( 1.10X19MM) 7" TUBE MYCO RE-ORDER # 7001P-19L