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| 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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