Primary Device ID | 40331330250000 |
NIH Device Record Key | 7cb22e16-ae4d-4398-b5cf-448280b06106 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Custodiol |
Version Model Number | 2 x 5000 ml |
Company DUNS | 316512953 |
Company Name | Dr. Franz Köhler Chemie GmbH |
Device Count | 2 |
DM Exempt | false |
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 | 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 |
Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
Storage Environment Temperature | Between 35 Degrees Fahrenheit and 59 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
Storage Environment Temperature | Between 35 Degrees Fahrenheit and 59 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 40331330050006 [Unit of Use] |
GS1 | 40331330250000 [Primary] |
KDN | System, Perfusion, Kidney |
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 | 2016-09-19 |
40331330610002 | 6 x 1000 ml |
40331330420007 | 4 x 2000 ml |
40331330250000 | 2 x 5000 ml |
40331330105003 | 10 x 500 ml |
40331330050006 | 5000 ml |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CUSTODIOL 75093836 2221916 Live/Registered |
Dr. Franz Kohler Chemie GmbH 1996-04-25 |