DEVICE: Provox® FreeHands HME® Moist (07331791008382)

Download: XML | JSON

Device Identifier (DI) Information

Provox® FreeHands HME® Moist
Moist
8222
Atos Medical AB
07331791008382
GS1
20
Provox ® FreeHands HME Moist / Flow are designed to allow automatic tracheostoma closure for voice prosthesis users while providing heat and moisture exchange for pulmonary rehabilitation.
CLOSE

Device Characteristics

MR Safe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Tracheostomy tube speech valve A device that is attached to a tracheostomy tube and is designed to eliminate the necessity of finger occlusion, enabling the tracheostomized patient to speak easily and more clearly. It can be made of metal [e.g., silver (Ag)] or plastic. This is a reusable device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EWL Prosthesis, Laryngeal (Taub)
CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep dry. Keep away from sunlight.
Handling Environment Temperature: between 36 and 108 Degrees Fahrenheit
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
September 11, 2016

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
No Package DIs found
CLOSE

Secondary DI

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

Unit of Use DI

[?]
Unit of Use DI Number: 07331791010613 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+4641519800
info@atosmedical.com
CLOSE