Accu-Read

GUDID 20858293006438

BP Cuff, Adult Large, 1 Tube BP00-2105 = 5 pack BP00-2120 = 20 pack

REPROCESSING PRODUCTS CORPORATION

Blood pressure cuff, reusable

• Primary Device ID: 20858293006438
• NIH Device Record Key: de3fe0fe-93fd-4ec8-b22c-858b14c0df99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Read
• Version Model Number: BP00-2101
• 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: false
• 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	00858293006434 [Primary]
GS1	10858293006431 [Package]; Contains: 00858293006434; Package: Bag [5 Units]; In Commercial Distribution
GS1	20858293006438 [Package]; Contains: 00858293006434; Package: Bag [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171889

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: 2019-09-06
• Device Publish Date: 2019-08-29

On-Brand Devices [Accu-Read]

• 10858293006448: BP Cuff, Adult Thigh, 1 Tube BP00-3105 = 5 pack
• 20858293006438: BP Cuff, Adult Large, 1 Tube BP00-2105 = 5 pack BP00-2120 = 20 pack
• 20858293006421: BP Cuff, Adult Regular, 1 tube BP00-1105 = 5 pack BP00-1120 = 20 pack
• 20858293006414: BP Cuff, Adult Sm, 1 tube BP00-0105 = 5 pack BP00-0120 = 20 pack