DEVICE: DOPPLEX (05051968013095)
Device Identifier (DI) Information
DOPPLEX
ACC160
In Commercial Distribution
ACC160
HUNTLEIGH HEALTHCARE LIMITED
ACC160
In Commercial Distribution
ACC160
HUNTLEIGH HEALTHCARE LIMITED
LRGE ADLT ARM BP CUFF-CL(31-40CM)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
34978 | Blood pressure cuff, reusable |
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 wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KNG | Monitor, Ultrasonic, Fetal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K930200 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 10 and 30 Degrees Celsius |
Storage Environment Temperature: between -10 and 40 Degrees Celsius |
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Humidity: less than 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 860 and 1060 millibar |
Storage Environment Atmospheric Pressure: between 860 and 1060 millibar |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
a37dd3b9-74df-49f7-ad94-5c21fce9c1d4
December 16, 2021
5
September 19, 2016
December 16, 2021
5
September 19, 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 |
---|---|---|---|---|---|
No Package DIs found |
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
[?]
+4402920485885
sales@huntleigh-diagnostics.co.uk
sales@huntleigh-diagnostics.co.uk