DEVICE: galemed (04710810087394)

Device Identifier (DI) Information

galemed
38023
In Commercial Distribution
Disposable Humidification Chamber - Auto feeding (IV:120cm)
GALEMED CORPORATION
04710810087394
GS1

1
656854379 *Terms of Use
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
No
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
42909 Ventilator IMV supplemental circuit, reusable
A device designed to provide mandatory breathes to ventilator patients to supplement the spontaneous respiratory rate. It is typically constructed of durable materials and consists of tubing and one-way valves. It will be used as an accessory on older ventilators without built-in intermittent mandatory ventilation (IMV) functions. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
BZO Set, Tubing And Support, Ventilator (W Harness)
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Atmospheric Pressure: between -40 and 60 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

ef33582a-25d3-42fa-93d3-1654a6172248
March 29, 2018
2
October 15, 2015
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
44710810087392 50 04710810087394 In Commercial Distribution Carton
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE