SoftCheck

GUDID 10858293006578

BP Cuff, Regular Adult, 26-35 cm, 1 Tube

REPROCESSING PRODUCTS CORPORATION

Blood pressure cuff, single-use

• Primary Device ID: 10858293006578
• NIH Device Record Key: 4abc209b-4075-4bcd-8242-cf8b798aa3d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SoftCheck
• Version Model Number: ST2635FL
• 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: 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	00858293006571 [Primary]
GS1	10858293006578 [Package]; Contains: 00858293006571; Package: Bag [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940214

FDA Product Code

• DXQ: Blood Pressure Cuff

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: 2019-09-09
• Device Publish Date: 2019-08-30

On-Brand Devices [SoftCheck]

• 10858293006660: BP Cuff, Thigh, 42-50 cm, 1 Tube
• 10858293006653: BP Cuff, Thigh, 42-50 cm, 1 Tube
• 10858293006646: BP Cuff, Large Adult Long, 35-44 cm, 1 Tube
• 10858293006639: BP Cuff, Large Adult Long, 35-44 cm, 1 Tube
• 10858293006622: BP Cuff, Large Adult, 32-42 cm, 1 Tube
• 10858293006615: BP Cuff, Large Adult, 32-42 cm, 1 Tube
• 10858293006608: BP Cuff, Long Adult, 29-38 cm, 1 Tube
• 10858293006592: BP Cuff, Long Adult, 29-38 cm, 1 Tube
• 10858293006585: BP Cuff, Regular Adult, 26-35 cm, 1 Tube
• 10858293006578: BP Cuff, Regular Adult, 26-35 cm, 1 Tube
• 10858293006561: BP Cuff, Small Adult, 18-26 cm, 1 Tube
• 10858293006554: BP Cuff, Small Adult, 18-26 cm, 1 Tube
• 10858293006547: BP Cuff, Child, 13-20 cm, 1 Tube
• 10858293006530: BP Cuff, Child, 13-20 cm, 1 Tube
• 10858293006523: BP Cuff, Infant, 8-14 cm, 1 Tube
• 10858293006516: BP Cuff, Infant, 8-14 cm, 1 Tube