E-Z Chek 5116A

GUDID 00858293006373

6.8-8.5 pH Test Strips acid/bicarbonate dialysate K100-0117 5/pack

REPROCESSING PRODUCTS CORPORATION

Haemodialysis treatment kit

• Primary Device ID: 00858293006373
• NIH Device Record Key: 5b039332-8820-4c3d-a43a-303e3effdb34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-Z Chek
• Version Model Number: 5116A
• Catalog Number: 5116A
• 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	00858293006373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101750

FDA Product Code

• MNV: Strip, Dialysate Ph Indicator

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-16
• Device Publish Date: 2017-03-07

Devices Manufactured by REPROCESSING PRODUCTS CORPORATION

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• 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