Plasmaflo
GUDID 04537693005365
The Plasmaflo OP-05W(A) Asahi plasma separator is a medical device intended for the therapeutic separation of plasma from the whole blood in a clinica
ASAHIKASEI MEDICAL MT K.K.
Apheresis system filter, whole blood Apheresis system filter, whole blood Apheresis system filter, whole blood Apheresis system filter, whole blood Apheresis system filter, whole blood Apheresis system filter, whole blood Apheresis system filter, whole blood Apheresis system filter, whole blood Apheresis system filter, whole blood Apheresis system filter, whole blood Apheresis system filter, whole blood Apheresis system filter, whole blood Apheresis system filter, whole blood Apheresis system filter, whole blood Apheresis system filter, whole blood| Primary Device ID | 04537693005365 |
| NIH Device Record Key | 5ee01d68-f06a-4ee5-b02a-554d50793406 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Plasmaflo |
| Version Model Number | OP-05W(A) |
| Company DUNS | 692097404 |
| Company Name | ASAHIKASEI MEDICAL MT K.K. |
| 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 | 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 |
Customer Support Contacts
| Phone | 800-526-3522 |
| xx@xx.xx | |
| Phone | 800-526-3522 |
| xx@xx.xx | |
| Phone | 800-526-3522 |
| xx@xx.xx | |
| Phone | 800-526-3522 |
| xx@xx.xx | |
| Phone | 800-526-3522 |
| xx@xx.xx | |
| Phone | 800-526-3522 |
| xx@xx.xx | |
| Phone | 800-526-3522 |
| xx@xx.xx | |
| Phone | 800-526-3522 |
| xx@xx.xx | |
| Phone | 800-526-3522 |
| xx@xx.xx | |
| Phone | 800-526-3522 |
| xx@xx.xx | |
| Phone | 800-526-3522 |
| xx@xx.xx | |
| Phone | 800-526-3522 |
| xx@xx.xx | |
| Phone | 800-526-3522 |
| xx@xx.xx | |
| Phone | 800-526-3522 |
| xx@xx.xx | |
| Phone | 800-526-3522 |
| xx@xx.xx |
Operating and Storage Conditions
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04537693005365 [Primary] |
| GS1 | 14537693005362 [Package] Contains: 24537693005369 Package: carton (outer) [2 Units] In Commercial Distribution |
| GS1 | 24537693005369 [Package] Package: carton (inner) [3 Units] In Commercial Distribution |
FDA Product Code
| MDP | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-08-30 |
| Device Publish Date | 2014-09-23 |
Devices Manufactured by ASAHIKASEI MEDICAL MT K.K.
| 04537693005365 - Plasmaflo | 2018-08-30The Plasmaflo OP-05W(A) Asahi plasma separator is a medical device intended for the therapeutic separation of plasma from the whole blood in a clinica |
| 04537693005365 - Plasmaflo | 2018-08-30 The Plasmaflo OP-05W(A) Asahi plasma separator is a medical device intended for the therapeutic separation of plasma from th |
| 04537693003897 - REXEED | 2018-03-29 Intended for use in hemodialysis for the treatment of patients suffering from acute or chronic renal failure. |
| 14537693003900 - REXEED | 2018-03-29 Intended for use in hemodialysis for the treatment of patients suffering from acute or chronic renal failure. |
| 14537693003917 - REXEED | 2018-03-29 Intended for use in hemodialysis for the treatment of patients suffering from acute or chronic renal failure. |
| 14537693003924 - REXEED | 2018-03-29 Intended for use in hemodialysis for the treatment of patients suffering from acute or chronic renal failure. |
Trademark Results [Plasmaflo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PLASMAFLO 87066329 5168444 Live/Registered |
DESERT LAKE TECHNOLOGIES, LLC 2016-06-09 |
 PLASMAFLO 73198401 1246970 Live/Registered |
Asahi Medical Co., Ltd. 1978-12-28 |
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