Primary Device ID | 00858526006743 |
NIH Device Record Key | 532934e4-cb44-4308-bf28-94ce5e014e1b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Accent 800 |
Version Model Number | ACN800-40 |
Company DUNS | 080143399 |
Company Name | PRENTKE ROMICH COMPANY |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | true |
Phone | 800-262-1984 |
info@prentrom.com | |
Phone | 800-262-1984 |
info@prentrom.com | |
Phone | 800-262-1984 |
info@prentrom.com | |
Phone | 800-262-1984 |
info@prentrom.com |
Weight | 2.45 Pound |
Weight | 2.45 Pound |
Weight | 2.45 Pound |
Weight | 2.45 Pound |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00858526006743 [Primary] |
ILQ | System, Communication, Powered |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-15 |
Device Publish Date | 2022-12-07 |
00858526006651 | Accent™ 800 is an integrated speech device and offers advanced functionality and user-friendly |
00858526006040 | Accent™ 800 is an integrated speech device and offers advanced functionality and user-friendly |
00858526006743 | Accent® 800 is an integrated speech device and offers advanced functionality and user-friendly |