Primary Device ID | 00310144300011 |
NIH Device Record Key | e1d0cf31-04c6-4d02-a798-dcbdd3f0967d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | INBRIJA® |
Version Model Number | Inbrija Device |
Company DUNS | 963845136 |
Company Name | Acorda Therapeutics, Inc. |
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 | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)367-5109 |
acordamc@eversana.com | |
Phone | +1(800)367-5109 |
acordamc@eversana.com | |
Phone | +1(800)367-5109 |
acordamc@eversana.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00310144300011 [Primary] |
KCO | Nasal spray, ENT delivery |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-06 |
Device Publish Date | 2022-11-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INBRIJA 87980717 5875276 Live/Registered |
ACORDA THERAPEUTICS, INC. 2017-05-26 |
INBRIJA 87465405 not registered Live/Pending |
ACORDA THERAPEUTICS, INC. 2017-05-26 |
INBRIJA 87465372 not registered Live/Pending |
ACORDA THERAPEUTICS, INC. 2017-05-26 |
INBRIJA 86717358 not registered Live/Pending |
ACORDA THERAPEUTICS, INC. 2015-08-06 |