CLASSIC-CUF

GUDID 00195278197160

CLASSIC-CUF ISO, ADULT, DINACLICK, 23 - 33 CM, 80369-5, SINGLE

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Blood pressure cuff, reusable

• Primary Device ID: 00195278197160
• NIH Device Record Key: 001d39f9-0994-4c30-b3bd-4fa9761a7a09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLASSIC-CUF
• Version Model Number: CLA-A2-2A-X-5S
• Company DUNS: 006580799
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278025296 [Primary]
GS1	00195278197160 [Package]; Contains: 00195278025296; Package: Pack [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-10
• Device Publish Date: 2021-08-02

On-Brand Devices [CLASSIC-CUF]

• 00840682114813: 2300
• 00840682109727: 2303
• 00840682114837: 2304
• 00840682114974: 2305
• 00840682109628: 2302
• 00840682115056: 2301
• 00840682109178: 2638
• 00840682109413: 2306
• 00840682114745: 2613
• 00840682109017: 2176
• 00840682114875: CLA-N2-1B
• 00840682109390: CLA-N3-1B
• 00840682109314: CLA-N1-1B
• 00840682109543: 2173
• 00840682109093: 2307
• 00840682109192: 2619
• 00840682109239: 2628
• 00840682109536: CLA-N1-2B
• 00840682109352: CLA-N4-2B
• 00840682109475: 2119
• 00840682109581: 2133
• 00840682114899: 2608
• 00840682109116: CLA-N5-1B
• 00840682109468: 2138
• 00840682108997: 2177
• 00840682109246: 2123
• 00840682109031: 2128
• 00840682109499: 2172
• 00840682109253: 2174
• 00840682109321: 2623
• 00840682109277: 2171
• 00840682109185: CLA-N2-2B
• 00840682109123: 2633
• 00840682109208: CLA-N5-2B
• 00840682109345: CLA-N3-2B
• 00840682109338: CLA-N4-1B
• 00840682109567: 2175
• 00840682109048: 2170
• 00840682108812: 2358
• 00840682108829: 2359
• 00840682115414: 2603
• 00840682108768: 2357
• 00840682108751: 2675
• 00840682108478: CLA-P1-2A
• 00840682108539: 2355
• 00840682108355: CLA-P2-2A
• 00840682108546: 2356
• 00840682108270: 2354
• 00840682108294: 2353
• 00840682108454: 2352