DEVICE: simex (04052262385957)
Device Identifier (DI) Information
simex
SIMEX cuff M
In Commercial Distribution
100678-3
SIMEX Medizintechnik GmbH
SIMEX cuff M
In Commercial Distribution
100678-3
SIMEX Medizintechnik GmbH
SIMEX cuff M suction
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? |
---|---|---|---|---|
61258 | Multi-purpose low-vacuum suction system |
An assembly of devices designed to generate a low vacuum [typically <400 millimetre(s) of mercury (mmHg)] for a variety of clinical applications (e.g., thoracic drainage, negative pressure wound therapy, endoluminal vacuum therapy, subglottic suctioning); it may be software limited to a single intended use whereby upgrade is possible. It consists of a mains electricity (AC-powered) suction pump (which may include a rechargeable battery) with software, controls, and a pressure regulator, a collection canister(s), tubing, and bacteria filter; it may also include patient contact devices. The low vacuum level is intended to reduce the risk of trauma.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BTA | Pump, Portable, Aspiration (Manual Or Powered) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K141255 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Atmospheric Pressure: between 82.5 and 106 KiloPascal |
Storage Environment Humidity: between 5 and 93 Percent (%) Relative Humidity |
Storage Environment Temperature: between -25 and 60 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
7d48de60-6832-4f78-8bfc-d28e09af6f33
July 06, 2018
3
September 12, 2016
July 06, 2018
3
September 12, 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
[?]
+49742092040
info@simexmed.de
info@simexmed.de