| Primary Device ID | 08720299213647 |
| NIH Device Record Key | 1fbf9f16-3268-4e32-8abf-12ff45e6797b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 2L MC Bottle |
| Version Model Number | 2LM-04-01 |
| Company DUNS | 493047487 |
| Company Name | Scinus Cell Expansion Netherlands B.V. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08720299213647 [Primary] |
| KJF | System, Suspension, Cell Culture |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[08720299213647]
Radiation Sterilization
[08720299213647]
Radiation Sterilization
[08720299213647]
Radiation Sterilization
[08720299213647]
Radiation Sterilization
[08720299213647]
Radiation Sterilization
[08720299213647]
Radiation Sterilization
[08720299213647]
Radiation Sterilization
[08720299213647]
Radiation Sterilization
[08720299213647]
Radiation Sterilization
[08720299213647]
Radiation Sterilization
[08720299213647]
Radiation Sterilization
[08720299213647]
Radiation Sterilization
[08720299213647]
Radiation Sterilization
[08720299213647]
Radiation Sterilization
[08720299213647]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-22 |
| Device Publish Date | 2021-01-14 |
| 08720299213630 - 2L Buffer Bottle | 2021-01-22 This bottle can be used for slowly medium refreshment of the e.g. Adherent Bag. And, the addition and removal of liquids to/from |
| 08720299213647 - 2L MC Bottle | 2021-01-22This bottle can be used for the hydration of microcarriers and to reconstitute them in medium. And, the addition of the microcarriers to the Adherent Bag. |
| 08720299213647 - 2L MC Bottle | 2021-01-22 This bottle can be used for the hydration of microcarriers and to reconstitute them in medium. And, the addition of the microca |
| 08720299213616 - Scinus Cell Expansion System | 2020-12-17 For the adherent cell culture inside the SCINUS the Adherent Bag is used. This Adherent Bag is intended exclusively for use with |
| 08720299213609 - Scinus Cell Expansion System | 2020-12-16 The SCINUS consists of a cabinet that encloses a temperature-controlled environment where a Single Use Bag can be mounted on a m |