Primary Device ID | 35020583103109 |
NIH Device Record Key | 63a47c88-32ed-43ab-86fc-23cb092bd8bb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Spectra Optia IDL Set |
Version Model Number | 10310 |
Company DUNS | 801679200 |
Company Name | TERUMO BCT, INC. |
Device Count | 6 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(303)205-2510 |
FDAUDIprogram@terumobct.com | |
Phone | +1(303)205-2510 |
FDAUDIprogram@terumobct.com |
Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05020583103108 [Unit of Use] |
GS1 | 35020583103109 [Primary] |
GKT | Separator, automated, blood cell, diagnostic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-15 |
35020583123206 | Spectra Optia IDL Set |
35020583103109 | Spectra Optia IDL Set |
35020583103000 | Spectra Optia IDL Set |