EXEL 84" Primary Solution Set 27085

GUDID 00020221270853

Filtered IV Administration Set, 20 drops/ml, Luer Lock, needle-free injection site, 84" tubing

Exel International

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• Primary Device ID: 00020221270853
• NIH Device Record Key: cd8f83dc-11b7-4d8d-9040-ac848162a670
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXEL 84" Primary Solution Set
• Version Model Number: 27085
• Catalog Number: 27085
• Company DUNS: 180572216
• Company Name: Exel International
• 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	00020221270853 [Primary]
GS1	10020221270850 [Package]; Package: [50 Units]; In Commercial Distribution
GS1	20020221270857 [Package]; Contains: 10020221270850; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031500

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: 2019-12-11
• Device Publish Date: 2016-09-23

On-Brand Devices [EXEL 84" Primary Solution Set]

• 00020221270853: Filtered IV Administration Set, 20 drops/ml, Luer Lock, needle-free injection site, 84" tubing
• 20020221260858: Filtered IV Administration Set, 20 drops/ml, Luer Lock, latex-free injection site, 84" tubing