Primary Device ID | 00858526006705 |
NIH Device Record Key | 368719f3-4f61-4318-bfcb-8f6d4c2d01dc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Accent 1400 |
Version Model Number | ACN1400-30 |
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 | 800-262-1990 |
service@prentrom.com |
Weight | 5.9 Pound |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00858526006705 [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 | 2020-04-08 |
Device Publish Date | 2020-03-31 |
00858526006002 | Accent™ 1400 is a dedicated speech-generating device (SGD) that offers user-friendly features |
00858526006705 | Accent™ 1400 is a dedicated speech-generating device (SGD) that offers user-friendly features |