SaniGuard 7001-3915

GUDID 20858293006025

Non-injectable Catheter Cap

REPROCESSING PRODUCTS CORPORATION

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• Primary Device ID: 20858293006025
• NIH Device Record Key: 5946582d-13ab-487a-bc1d-82821bdedf67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SaniGuard
• Version Model Number: 7001-3915
• Catalog Number: 7001-3915
• Company DUNS: 796083392
• Company Name: REPROCESSING PRODUCTS CORPORATION
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858293006021 [Primary]
GS1	10858293006028 [Package]; Contains: 00858293006021; Package: package [100 Units]; In Commercial Distribution
GS1	20858293006025 [Package]; Contains: 00858293006021; Package: package [2000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K852605

FDA Product Code

• FJK: Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

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: 2018-07-06
• Device Publish Date: 2017-01-19

Devices Manufactured by REPROCESSING PRODUCTS CORPORATION

• 00858293006922 - Micro-X: 2023-02-28 Micro-X Disinfectant/Sterilant
• 00858293006885 - Spiral Coil Tubing, Clear: 2021-05-25 Spiral Coil Tubing 1/16 x 8, Clear
• 00858293006892 - Spiral Coil Tubing, Trans Red: 2021-05-25 Spiral Coil Tubing, .160 x 8, Trans Red
• 00858293006908 - Spiral Coil Tubing, Trans Blue: 2021-05-25 Spiral Coil Tubing, .160 x 8, Trans Blue
• 00858293006878 - Sani-lok Blood Port Barrier Adaptor: 2021-05-21 Blood Port Barrier Adaptor
• 00858293006847 - E-Z Draw Sample Port: 2021-04-14 D300-2011 E-Z Draw Sample Port
• 00858293006830 - E-Z Draw: 2020-10-21 Sample Port
• 10858293006448 - Accu-Read: 2019-09-09 BP Cuff, Adult Thigh, 1 Tube BP00-3105 = 5 pack