plasmatherm 212.10046
GUDID 04059201000001
Thawing and warming device for frozen Plasma (FFP, PF24, AHF), Whole Blood, RBC and IV solution
Barkey GmbH & Co. KG
Plasma thawing unit| Primary Device ID | 04059201000001 |
| NIH Device Record Key | ee273696-ba0e-4853-a48c-b8a5c8306956 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | plasmatherm |
| Version Model Number | US |
| Catalog Number | 212.10046 |
| Company DUNS | 312555782 |
| Company Name | Barkey GmbH & Co. KG |
| Device Count | 1 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | false |
Customer Support Contacts
| Phone | +12017081400 |
| info@genesisbps.com | |
| Phone | +12017081400 |
| info@genesisbps.com | |
| Phone | +12017081400 |
| info@genesisbps.com | |
| Phone | +12017081400 |
| info@genesisbps.com | |
| Phone | +12017081400 |
| info@genesisbps.com | |
| Phone | +12017081400 |
| info@genesisbps.com | |
| Phone | +12017081400 |
| info@genesisbps.com | |
| Phone | +12017081400 |
| info@genesisbps.com | |
| Phone | +12017081400 |
| info@genesisbps.com | |
| Phone | +18662275393 |
| info@barkey-us.com | |
| Phone | +18662275393 |
| info@barkey-us.com | |
| Phone | +18662275393 |
| info@barkey-us.com | |
| Phone | +18662275393 |
| info@barkey-us.com | |
| Phone | +18662275393 |
| info@barkey-us.com | |
| Phone | +18662275393 |
| info@barkey-us.com | |
| Phone | +18662275393 |
| info@barkey-us.com | |
| Phone | +18662275393 |
| info@barkey-us.com | |
| Phone | +18662275393 |
| info@barkey-us.com | |
| Phone | +18662275393 |
| info@barkey-us.com | |
| Phone | +18662275393 |
| info@barkey-us.com | |
| Phone | +18662275393 |
| info@barkey-us.com | |
| Phone | +18662275393 |
| info@barkey-us.com |
Operating and Storage Conditions
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04059201000001 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- BK100063
FDA Product Code
| KZL | Device, Warming. Blood And Plasma |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-13 |
On-Brand Devices [plasmatherm]
| 04059201000018 | Thawing and warming device for frozen Plasma (FFP, PF24, AHF), Whole Blood, RBC and IV solution |
| 04059201000001 | Thawing and warming device for frozen Plasma (FFP, PF24, AHF), Whole Blood, RBC and IV solution |
Trademark Results [plasmatherm]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PLASMATHERM 79064974 3699207 Live/Registered |
Barkey GmbH & Co. KG 2008-07-18 |
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