DEVICE: CLASSIC-CUF (00840682108317)
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If so, send a picture of the label to
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Device Identifier (DI) Information
CLASSIC-CUF
CLA-T1-2A-X
Not in Commercial Distribution
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CLA-T1-2A-X
Not in Commercial Distribution
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CLASSIC-CUF ISO, THIGH, DINACLICK, 38 - 50 CM, SINGLE
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| Yes | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 37326 | Blood pressure cuff, single-use |
A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is typically wrapped around the upper arm of the patient. This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| DXQ | blood pressure cuff |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K120125 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature: between -20 and 55 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: Thigh |
Device Record Status
c89936f3-2b20-4286-bd53-7d81d5bccd2d
April 17, 2025
4
June 30, 2016
April 17, 2025
4
June 30, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 00840682108423 | 20 | 00840682108317 | 2025-04-01 | Not in Commercial Distribution |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)558-5120
xx@xx.xx
xx@xx.xx