Primary Device ID | 00815696020627 |
NIH Device Record Key | 6f506498-0244-4685-a76f-8e7b0d46a85d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | George King Factor VIII Deficient Plasma with Inhibitor |
Version Model Number | 1800-1.0 |
Company DUNS | 066761271 |
Company Name | GEORGE KING BIO-MEDICAL, 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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
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 | 1-800-255-5108 |
plasma@kingbiomed.com | |
Phone | 1-800-255-5108 |
plasma@kingbiomed.com | |
Phone | 1-800-255-5108 |
plasma@kingbiomed.com |
Special Storage Condition, Specify | Between 0 and 0 *-70˚C or below |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00815696020627 [Primary] |
GGC | Control, Plasma, Abnormal |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-08-18 |
00815696020733 | George King Factor VIII Deficient plasma with Inhibitor is fresh frozen citrated human plasma de |
00815696020627 | George King Factor VIII Deficient plasma with Inhibitor is fresh frozen citrated human plasma de |
00815696021181 | George King Factor VIII Deficient Plasma with Inhibitor is fresh frozen citrated human plasma de |
00815696021174 | George King Factor VIII Deficient Plasma with Inhibitor is fresh frozen citrated human plasma de |
00815696021167 | George King Factor VIII Deficient Plasma with Inhibitor is fresh frozen citrated human plasma de |