Fenestrated NeoDrape ND-FS

GUDID 20817584013371

Fenestrated NeoDrape

NEOMED, INC.

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• Primary Device ID: 20817584013371
• NIH Device Record Key: 2c86a165-b5c1-4e98-8f0d-ca856e2e418a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fenestrated NeoDrape
• Version Model Number: ND-FS
• Catalog Number: ND-FS
• Company DUNS: 799772079
• Company Name: NEOMED, INC.
• 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817584013374 [Primary]
GS1	20817584013371 [Package]; Contains: 10817584013374; Package: Case [40 Units]; In Commercial Distribution

FDA Product Code

• FME: Gown, Examination

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-02-05
• Device Publish Date: 2020-05-19

Devices Manufactured by NEOMED, INC.

• 10817584013336 - NeoDrape: 2021-02-05 NeoDrape
• 20817584013371 - Fenestrated NeoDrape: 2021-02-05Fenestrated NeoDrape
• 20817584013371 - Fenestrated NeoDrape: 2021-02-05 Fenestrated NeoDrape
• 00817584013384 - NeoConnect Press-in Bottle Adapter: 2020-09-30 NeoMed NeoConnect Press-in Bottle Adapter, Size E
• 10817584013404 - NeoConnect Press-in Bottle Adapter: 2020-09-30 NeoMed NeoConnect Press-in Bottle Adapter, Size D
• 20817584013203 - NeoConnect Oral / Enteral Syringe, OTC: 2020-01-22 3mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC
• 20817584013210 - NeoConnect Oral / Enteral Syringe, OTC: 2020-01-22 6mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC
• 20817584013227 - NeoConnect Oral / Enteral Syringe, OTC: 2020-01-22 12mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC
• 10817584013237 - NeoConnect Oral / Enteral Syringe, OTC: 2020-01-22 60mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC