Primary Device ID | 37332414066315 |
NIH Device Record Key | df402d02-62f8-489c-93e0-af4d91712868 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DIACLEAR |
Version Model Number | 106887 |
Catalog Number | 106887 |
Company DUNS | 393020474 |
Company Name | GAMBRO INDUSTRIES |
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 | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07332414066314 [Primary] |
GS1 | 37332414066315 [Package] Contains: 07332414066314 Package: CASE [12 Units] In Commercial Distribution |
FIP | SUBSYSTEM, WATER PURIFICATION |
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 | 2016-09-24 |
50085412917691 - PRISMAFLEX SET | 2022-11-30 Disposable extracorporeal circuit |
50085412954078 - PRISMAFLEX SET | 2022-11-30 Disposable extracorporeal circuit |
50085412954108 - PRISMAFLEX SET | 2022-11-30 Disposable extracorporeal circuit |
37332414064540 - PRISMAFLEX SET | 2020-02-13 The Prismaflex M60 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries |
37332414064557 - PRISMAFLEX SET | 2020-02-13 The Prismaflex M100 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countrie |
37332414069316 - PRISMAFLEX SET | 2020-02-13 The Prismaflex HF1400 set is indicated for use only with the PrismaFlex system or with the PrisMax system (in countries where Pr |
37332414090006 - PRISMAFLEX SET | 2020-02-13 The Prismaflex M150 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countrie |
07332414111038 - PRISMAFLEX TPE 2000 SET | 2020-02-13 The Prismaflex TPE2000 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in count |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DIACLEAR 78174653 2841739 Live/Registered |
Gambro Lundia AB 2002-10-15 |
DIACLEAR 74357241 1797504 Dead/Cancelled |
Plunk, Larry D. 1993-02-05 |
DIACLEAR 74164998 not registered Dead/Abandoned |
Plunk, Larry D. 1991-05-09 |
DIACLEAR 72043358 0666295 Dead/Expired |
WALLACE, DAVIS COMPANY, THE 1958-01-02 |