SOFT-CUF
GUDID 00840682107525
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Blood pressure cuff, reusable| Primary Device ID | 00840682107525 |
| NIH Device Record Key | c860e933-2493-494f-b33e-cb927777b58f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SOFT-CUF |
| Version Model Number | 2503-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 |
| 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 |
Operating and Storage Conditions
| 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 | 00840682106795 [Primary] |
| GS1 | 00840682107525 [Package] Contains: 00840682106795 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]
Trademark Results [SOFT-CUF]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOFT-CUF 75722565 2505153 Live/Registered |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 1999-06-08 |
 SOFT-CUF 72383708 0964918 Dead/Expired |
FOREGGER COMPANY, INC., THE 1971-02-12 |
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