R12576 M4RTUniversal Plus Swab Kit PK/100

GUDID 00848838018510

Remel Inc.

Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium

• Primary Device ID: 00848838018510
• NIH Device Record Key: 88077269-75ef-4401-9725-53cdc60acc4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R12576 M4RTUniversal Plus Swab Kit PK/100
• Version Model Number: R12576
• Company DUNS: 118161628
• Company Name: Remel Inc.
• 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: true
• Expiration Date: true
• 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	00848838018510 [Primary]

FDA Product Code

• JSM: Culture Media, Non-Propagating Transport

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: 2024-04-08
• Device Publish Date: 2024-03-29

Devices Manufactured by Remel Inc.

• 00848838018510 - R12576 M4RTUniversal Plus Swab Kit PK/100: 2024-04-08
• 00848838018510 - R12576 M4RTUniversal Plus Swab Kit PK/100: 2024-04-08
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