DEVICE: SOBERLINK (B90106)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
SOBERLINK
SOBERLINK LTE - 06
In Commercial Distribution

SOBERLINK HEALTHCARE LLC
B90106
HIBCC

1
079871438 *Terms of Use
No description.
CLOSE

Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
Yes
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?
36041 Alcohol breath analyser
A portable, battery-powered instrument intended to measure and document alcohol concentrations in human breath at the point-of-care.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DJZ Devices, Breath Trapping, Alcohol
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K160613 000
No CLOSE

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

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
33b729dc-432b-4580-8262-ea5b9042eca3
December 16, 2021
1
December 08, 2021
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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE