Product code KZL
- Device name
- Device, Warming. Blood And Plasma
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.9205
- 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 |
|---|---|---|---|
| K813489 | ROCKING/CIRCULATING CYTO-THERM II 3570 | Cryosan, Inc. | 1982-03-04 |
| K812311 | CIRCULATING CYTO-THERMS | Cryosan, Inc. | 1981-09-16 |
| K800699 | FLO TEM (FLUID WARNER) | Chroma Products, Inc. | 1980-05-08 |
| K790936 | MODEL 114 TREONIC H150 HAEMOHEATER | Vickers America Medical Corp. | 1979-09-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20695085001826 | Level 1 | ICU MEDICAL, INC. | 2026-01-08 |
| 10695085001829 | Level 1 | ICU MEDICAL, INC. | 2026-01-08 |
| 04038917968560 | SAHARA-TSC 115V | Sarstedt Aktiengesellschaft & Co.KG | 2023-11-24 |
| 00810144911137 | Redipor | AnalytiChem USA, Inc. | 2023-09-21 |
| 04038917968645 | SAHARA-III MAXITHERM 115V | Sarstedt Aktiengesellschaft & Co.KG | 2023-06-06 |
| 04038917968324 | SAHARA-III basic model 115V | Sarstedt Aktiengesellschaft & Co.KG | 2023-06-06 |
| 04059201002135 | Barkey plasmatherm C&G | Barkey GmbH & Co. KG | 2021-11-12 |
| 04059201001817 | Barkey plasmatherm C&G | Barkey GmbH & Co. KG | 2021-11-12 |
| 04059201001701 | Barkey plasmatherm V | Barkey GmbH & Co. KG | 2021-11-12 |
| 07290115270006 | ZipThaw™ 202 | FREMON SCIENTIFIC, INC. | 2020-03-06 |
| 20695085400100 | Level 1 | ICU MEDICAL, INC. | 2019-09-25 |
| 30695085400107 | Level 1 | SMITHS MEDICAL MD, INC. | 2019-09-25 |
| 20695085430008 | Level 1 | ICU MEDICAL, INC. | 2016-10-14 |
| 10695085430001 | Level 1 | Smiths Medical ASD, Inc. | 2016-10-14 |
| 50695085410018 | Level 1 | SMITHS MEDICAL MD, INC. | 2016-10-14 |
| 20695085406010 | Level 1 | ICU MEDICAL, INC. | 2016-10-14 |
| 10695085406006 | Level 1 | Smiths Medical ASD, Inc. | 2016-10-14 |
| 20695085406003 | Level 1 | ICU MEDICAL, INC. | 2016-10-14 |
| 20695085410017 | Level 1 | ICU MEDICAL, INC. | 2016-10-14 |
| 20695085430015 | Level 1 | ICU MEDICAL, INC. | 2016-10-14 |
| 30695085433006 | Level 1 | ICU MEDICAL, INC. | 2016-10-14 |
| 40695085400302 | Level 1 | ICU MEDICAL, INC. | 2016-10-14 |
| 40695085410004 | Level 1 | ICU MEDICAL, INC. | 2016-10-14 |
| 10695085800217 | Level 1 | ICU MEDICAL, INC. | 2016-10-14 |
| 30695085403108 | Level 1 | ICU MEDICAL, INC. | 2016-10-11 |
| 50695085403003 | Level 1 | ICU MEDICAL, INC. | 2016-10-11 |
| 30695085403603 | Level 1 | ICU MEDICAL, INC. | 2016-10-11 |
| 04028339710236 | SAHARA | Transmed Medizintechnik GmbH & Co. KG | 2016-08-15 |
| 04028339710939 | SAHARA | Transmed Medizintechnik GmbH & Co. KG | 2016-08-15 |
| 04028339720235 | SAHARA | Transmed Medizintechnik GmbH & Co. KG | 2016-08-15 |