Elite Mylar Blanket Not Applicable

GUDID 00816703023235

Elite Mylar Blanket

MEDSOURCE INTERNATIONAL LLC

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• Primary Device ID: 00816703023235
• NIH Device Record Key: dcc1532b-9b41-4307-9455-a36e16c88c59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite Mylar Blanket
• Version Model Number: ELITE-B100
• Catalog Number: Not Applicable
• Company DUNS: 041674552
• Company Name: MEDSOURCE INTERNATIONAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816703023228 [Primary]
GS1	00816703023235 [Package]; Contains: 00816703023228; Package: Case [200 Units]; In Commercial Distribution

FDA Product Code

• KME: Bedding, Disposable, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-10
• Device Publish Date: 2021-04-20

Devices Manufactured by MEDSOURCE INTERNATIONAL LLC

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• 00840155413962 - MedSource Catheters: 2023-10-16 ClearSafe Comfort Closed System Dual Port 20Gx1
• 00840155413993 - MedSource Winged Catheters: 2023-10-16 ClearSafe Comfort I.V. Catheter, 14g x1.25 pur, winged
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