CLASSIC-CUF
GUDID 00840682109079
CLASSIC-CUF, NEONATAL4, 2 TB MALE SLIP, 07 - 13 CM, SINGLE
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Blood pressure cuff, reusable| Primary Device ID | 00840682109079 |
| NIH Device Record Key | 4a53889d-5560-4177-aae7-dbd0c9e7b3b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CLASSIC-CUF |
| Version Model Number | 2623 |
| 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 | false |
| 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 |
Customer Support Contacts
| Phone | +1(800)558-5120 |
| xx@xx.xx | |
| Phone | +1(800)558-5120 |
| xx@xx.xx | |
| Phone | +1(800)558-5120 |
| xx@xx.xx | |
| Phone | +1(800)558-5120 |
| xx@xx.xx | |
| Phone | +1(800)558-5120 |
| xx@xx.xx | |
| Phone | +1(800)558-5120 |
| xx@xx.xx | |
| Phone | +1(800)558-5120 |
| xx@xx.xx | |
| Phone | +1(800)558-5120 |
| xx@xx.xx | |
| Phone | +1(800)558-5120 |
| xx@xx.xx | |
| Phone | +1(800)558-5120 |
| xx@xx.xx | |
| Phone | +1(800)558-5120 |
| xx@xx.xx | |
| Phone | +1(800)558-5120 |
| xx@xx.xx | |
| Phone | +1(800)558-5120 |
| xx@xx.xx | |
| Phone | +1(800)558-5120 |
| xx@xx.xx | |
| Phone | +1(800)558-5120 |
| xx@xx.xx | |
| Phone | +1(800)558-5120 |
| xx@xx.xx |
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 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 |
Operating and Storage Conditions
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682109079 [Primary] |
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 | 6 |
| Public Version Date | 2025-05-15 |
| Device Publish Date | 2016-06-30 |
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 |
Trademark Results [CLASSIC-CUF]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLASSIC-CUF 75724258 2398723 Live/Registered |
GE Medical Systems Information Technologies, Inc. 1999-06-08 |
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