SOFT-CUF

GUDID 00840682107303

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Blood pressure cuff, reusable

• Primary Device ID: 00840682107303
• NIH Device Record Key: a7199311-2c30-49f6-b025-a57dfe40ac74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOFT-CUF
• Version Model Number: SFT-A3-2A-INT
• Company DUNS: 784985108
• Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)558-5120
• Email: xx@xx.xx

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682107020 [Primary]
GS1	00840682107303 [Package]; Contains: 00840682107020; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120125

FDA Product Code

• DXQ: blood pressure cuff

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: 2019-07-22
• Device Publish Date: 2016-06-30

On-Brand Devices [SOFT-CUF]

• 00840682108164: 2505
• 00840682107501: 2363
• 00840682107426: 2364
• 00840682107297: 2140-INT
• 00840682107365: 2362-INT
• 00840682107464: SFT-A3-2A
• 00840682107211: SFT-A2-2A-L
• 00840682107488: SFT-P2-2A
• 00840682107372: SFT-A1-2A
• 00840682107358: SFT-A2-2A
• 00840682107280: 2116-INT
• 00840682108034: 2404-INT
• 00840682107303: SFT-A3-2A-INT
• 00840682107518: 2363-INT
• 00840682107440: 2403
• 00840682107839: 2506
• 00840682107792: 2324
• 00840682107563: SFT-A2-2A-L-INT
• 00840682107679: 2141
• 00840682107549: 2364-INT
• 00840682107327: SFT-P2-2A-INT
• 00840682107648: 2323
• 00840682107334: SFT-A2-2A-INT
• 00840682107341: 2504
• 00840682107532: 2403-INT
• 00840682107471: 2140
• 00840682115513: 2604
• 00840682107389: 2126
• 00840682107228: 2604-INT
• 00840682107525: 2503-INT
• 00840682107587: 2325
• 00840682107778: 2365
• 00840682107631: 2321
• 00840682107884: 2507
• 00840682107242: 2404
• 00840682107433: 2362
• 00840682107310: 2405-INT
• 00840682107686: 2322
• 00840682107402: 2502-INT
• 00840682107273: 2405
• 00840682107495: 2125
• 00840682107457: 2124
• 00840682107570: 2117
• 00840682107747: 2361
• 00840682107693: 2360
• 00840682107730: 2320
• 00840682107785: 2644
• 00840682107266: SFT-A1-2A-INT
• 00840682107235: 2116
• 00840682107259: 2503