Product code KSR
- Device name
- Container, Empty, For Collection & Processing Of Blood & Blood Components
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.9100
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K032827 | KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 | Tyco Healthcare | 2003-12-08 |
| K020753 | DEROYAL SURGICAL, UMBILICUP | Deroyal | 2002-06-13 |
| K810500 | BLOOD FREEZING BAG | Delmed, Inc. | 1981-09-23 |
| K810897 | ALPHA PLASTIC PLASMA BOTTLE | Alpha Therapeutic Corp. | 1981-09-23 |
| K811523 | PLASMA FLEX | Terumo America, Inc. | 1981-09-09 |
| K811449 | HAEMONETICS 1000ML COMPONENT BAG | Haemonetics Corp. | 1981-07-01 |
| K810711 | HAEMONETICS 600 ML. COMPONENT BAG | Haemonetics Corp. | 1981-05-08 |
| K810313 | HAEMONETICS 1400 ML THERAPEUTIC BAG | Haemonetics Corp. | 1981-03-31 |
| K801082 | GAMBRO HEMOFREEZE-BAG | Gambro, Inc. | 1980-10-31 |
| K801219 | PLASMAPOOLER | North American Biologicals, Inc. | 1980-10-31 |
| K792395 | PHARMAFLEX CRYOGENIC BAG | Pharmachem Corp. | 1980-02-26 |
| K792185 | PIASMA SAFE | Cry-O-Safe, Inc. | 1979-12-28 |
| K791673 | EMPTY TRANSFER BAG | Delmed, Inc. | 1979-10-23 |
| K781811 | TRANSFER PAK 4R 9006 | Travenol Laboratories, S.A. | 1978-11-08 |
| K780354 | CRYOCYTE PACK | Travenol Laboratories, S.A. | 1978-06-14 |
| K760952 | TERASAKI LYMPHOCYTE TRANSPORT KIT | Dravon Medical, Inc. | 1977-01-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10816203021103 | CryoStore Freezing Bag | ORIGEN BIOMEDICAL, INC. | 2024-12-06 |
| 10816203021127 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203020854 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203020939 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203020991 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203021028 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203021066 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203021073 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203020458 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203020410 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203020366 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203020359 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203021080 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203021097 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203021110 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203020908 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-22 |
| 10816203020847 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-22 |
| 10816203020892 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-22 |
| 10816203020878 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-22 |
| 10816203020830 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-22 |
| 10816203020786 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-22 |
| 10816203020724 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-09-22 |
| 10816203020717 | CryoStore | ORIGEN BIOMEDICAL, INC. | 2016-09-22 |
| 10811137010490 | Transfer Pack | FENWAL, INC. | 2016-09-12 |
| 10811137010636 | Transfer Pack | FENWAL, INC. | 2016-09-12 |
| 10811137010629 | Transfer Pack | FENWAL, INC. | 2016-09-12 |
| 10811137010612 | Transfer Pack | FENWAL, INC. | 2016-09-12 |
| 10811137010551 | Transfer Pack | FENWAL, INC. | 2016-09-12 |
| 10811137010544 | Transfer Pack | FENWAL, INC. | 2016-09-12 |
| 10816203020823 | Cryostore | ORIGEN BIOMEDICAL, INC. | 2016-05-27 |