| Primary Device ID | 04049934000317 | 
| NIH Device Record Key | d983f750-599b-4a35-8b6d-37419c0072a4 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | CryoMACS® Freezing Bag 1000 | 
| Version Model Number | 74404 | 
| Catalog Number | 200-074-404 | 
| Company DUNS | 327036034 | 
| Company Name | Miltenyi Biotec GmbH | 
| Device Count | 24 | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 04049934000317 [Primary] | 
| GS1 | 04049934001345 [Unit of Use] | 
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | 
| 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 | 2016-07-22 | 
| 04049934004674 - CliniMACS PBS/EDTA Buffer 1L | 2019-05-31 CliniMACS® PBS/EDTA Buffer is a single-use, sterile, isotonic buffer solution used as part of the CliniMACS CD34 Reagent System | 
| 04049934000270 - CryoMACS® Freezing Bag 50 | 2018-07-06 The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing, | 
| 04049934000287 - CryoMACS® Freezing Bag 250 | 2018-07-06 The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing, | 
| 04049934000294 - CryoMACS® Freezing Bag 500 | 2018-07-06 The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing, | 
| 04049934000300 - CryoMACS® Freezing Bag 750 | 2018-07-06 The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing, | 
| 04049934000317 - CryoMACS® Freezing Bag 1000 | 2018-07-06The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing, storage (down to -196°C | 
| 04049934000317 - CryoMACS® Freezing Bag 1000 | 2018-07-06 The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing, | 
| 04049934004636 - CliniMACS Plus Instrument | 2018-07-06 The CliniMACS® plus Instrument is a software-controlled instrument that processes the HPC, Apheresis as part of the CliniMACS C | 
| 04049934004672 - CliniMACS PBS/EDTA Buffer 1L | 2018-07-06 CliniMACS® PBS/EDTA Buffer is a single-use, sterile, isotonic buffer solution used as part of the CliniMACS CD34 Reagent System | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  CRYOMACS  79060203  3705509 Live/Registered | Miltenyi Biotec B.V. & Co. KG 2008-07-30 |