MedSource Linen Set Not Applicable

GUDID 00816703024232

Linen Set, 3 PC, w/ Heavy Duty Fitted

MEDSOURCE INTERNATIONAL LLC

Basic bed sheet, single-use Basic bed sheet, single-use Basic bed sheet, single-use Basic bed sheet, single-use Basic bed sheet, single-use Basic bed sheet, single-use Basic bed sheet, single-use Basic bed sheet, single-use Basic bed sheet, single-use Basic bed sheet, single-use Basic bed sheet, single-use Basic bed sheet, single-use Basic bed sheet, single-use Basic bed sheet, single-use

• Primary Device ID: 00816703024232
• NIH Device Record Key: 54e27bb9-7d8b-46d8-b59e-7cdea445421d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedSource Linen Set
• Version Model Number: MS-003PCHD
• 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: true
• 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	00816703024225 [Primary]
GS1	00816703024232 [Package]; Contains: 00816703024225; Package: Case [25 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-04
• Device Publish Date: 2021-04-26

On-Brand Devices [MedSource Linen Set]

• 00816703024270: Linen Set, 4 PC w/ Under Pad
• 00816703024232: Linen Set, 3 PC, w/ Heavy Duty Fitted