EXEL I.V. Administration Set 29082

GUDID 00020221290820

I.V. Administration Set, 15 drops/ml, Luer Lock, with Y-injection Site, Vented/Non Vented, with Clamp, 78" Tubing

Exel International

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• Primary Device ID: 00020221290820
• NIH Device Record Key: 28bce093-7083-47d4-9cab-7be17e8e2743
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXEL I.V. Administration Set
• Version Model Number: 29082
• Catalog Number: 29082
• 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	00020221290820 [Primary]
GS1	10020221290827 [Package]; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010404

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: 3
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-09-20

On-Brand Devices [EXEL I.V. Administration Set]

• 10020221290889: I.V. Administration Set, 15 drops/ml, Lock/Slip, 2 Injection Sites, Roller Clamp, 2 Occlusion C
• 10020221290865: I.V. Administration Set, 15 drops/ml, Lock/Slip, with Y-injection Site, Vented/Non Vented, with
• 00020221290851: I.V. Administration Set, 60 drops/ml, Luer Lock, with Y-injection Site, Vented/Non Vented, with
• 10020221290834: I.V. Administration Set, 60 drops/ml, Luer Slip, with Y-injection Site, Vented/Non Vented, with
• 00020221290820: I.V. Administration Set, 15 drops/ml, Luer Lock, with Y-injection Site, Vented/Non Vented, with
• 10020221290810: I.V. Administration Set, 15 drops/ml, Luer Slip, with Y-injection Site, Vented/Non Vented, with
• 10020221270867: I.V. Administration Set, 15 drops/ml, Lock/Slip, with Needle-Free Injection Site, Vented/Non Ven