ACP 215
- Primary DI
- 30812747015800
- Brand
- ACP 215
- Company
- HAEMONETICS CORPORATION
- Model
- 02215-110-E
- Device description
- ACP215, 110V, LN 02215-110-E
- Published
- 2017-01-31
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Contact Domains#
haemonetics.comProduct Codes#
| Code | Name |
|---|---|
| KSW | SYSTEM, PROCESSING FOR FROZEN BLOOD |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| KSW | System, Processing For Frozen Blood | Hematology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| BK030062 | 0 |
| BK040077 | 0 |
| BK060008 | 0 |
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| BK030062 | 0 | ||||
| BK040077 | 0 | ||||
| BK060008 | 0 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 30812747015800 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 30812747015800 | 30812747015800 |
GMDN Terms#
| Term | Definition |
|---|---|
| Blood cell freeze/thaw system | An assembly of devices designed for the automated processing of red blood cells received indirectly from a donor so that the cells can be safely frozen for storage in a closed, disposable set, and when needed, thawed for use. The assembly will typically add an appropriate substance (e.g., glycerol) to the blood cells to allow freezing, and facilitate the thawing process. The assembly may also wash the red blood cells to remove glycerol and plasma and extracellular components; it may also resuspend the cells in an additive solution. It will typically be comprised of pumps, a centrifuge, air detectors, a dedicated shaker, monitoring devices, disposable set, and possibly print-out facilities. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)-537-2802 | pirdesk@Haemonetics.com |
Regulatory Flags#
- DUNS number
- 057827420
- Device count
- 1
- Serial number
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10812747018203 | TEG5000 | 07-044 | 2017-05-30 | |
| 10812747018210 | TEG5000 | 07-045 | 2017-05-30 | |
| 10812747018296 | TEG6s HEMOSTASIS SYSTEM | 07-650-US | 2017-07-17 | |
| 10812747018302 | TEG6s HEMOSTASIS SYSTEM | 07-651-US | 2017-08-18 | |
| 10812747018326 | TEG6s HEMOSTASIS SYSTEM | 07-601-US | 2017-04-25 | |
| 10812747018340 | TEG6S HEMOSTASIS SYSTEM | 07-662US | 2017-07-17 | |
| 10812747018463 | Hemostasis System | 07-605-US | 2021-06-17 | |
| 10812747018531 | Global Hemostasis - HN | 07-604-US | 2024-04-10 | |
| 20812747018491 | Haemonetics TEG 6s | 07-664-US | 2021-06-17 | |
| 20812747018514 | Haemonetics TEG 6s | 07-665US | 2021-06-18 | |
| 20812747018002 | TEG5000 HEMOSTASIS SYSTEM | 07-004 | 2017-06-16 | |
| 20812747018019 | TEG5000 HEMOSTASIS SYSTEM | 07-006 | 2017-06-16 | |
| 20812747018026 | TEG5000 HEMOSTASIS SYSTEM | 07-007 | 2017-06-16 | |
| 20812747018033 | TEG5000 HEMOSTASIS SYSTEM | 07-008 | 2017-06-16 | |
| 10812747019859 | Haemonetics® NexSys PCS® System | 00620-NX | 2026-03-20 | |
| 30812747019853 | Haemonetics® NexSys PCS® System | 00620-NX | 2026-03-20 | |
| 30812747011659 | HAEMONETICS PCS 300 PLASMA COLLECTION SYSTEM | PCS-300-US | 2017-11-01 | |
| 10887691000116 | Haemonetics | PL1B | 2016-12-15 | |
| 10887691000161 | Haemonetics EZ Prime | RCEZ1T | 2016-12-15 | |
| 10887691000178 | Haemonetics | RCEZKS | 2022-03-15 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 30812747015183 | ACP 215 | HAEMONETICS CORPORATION | KSW | 2017-05-02 |
| 10812747015004 | HAEMONETICS ACP 215 SYSTEM | HAEMONETICS CORPORATION | KSW | 2017-02-07 |
| 10812747015011 | HAEMONETICS ACP 215 SYSTEM | HAEMONETICS CORPORATION | KSW | 2017-02-07 |
| 10812747015028 | HAEMONETICS ACP 215 SYSTEM | HAEMONETICS CORPORATION | KSW | 2017-02-07 |
| 30812747015008 | HAEMONETICS ACP 215 SYSTEM | HAEMONETICS CORPORATION | KSW | 2017-02-07 |
| 30812747015015 | HAEMONETICS ACP 215 SYSTEM | HAEMONETICS CORPORATION | KSW | 2017-02-07 |
| 30812747015022 | HAEMONETICS ACP 215 SYSTEM | HAEMONETICS CORPORATION | KSW | 2017-02-07 |
| 30812747015817 | ACP 215 | HAEMONETICS CORPORATION | KSW | 2017-01-31 |
| 00085412010717 | NA | BAXTER HEALTHCARE CORPORATION | KSW | 2016-09-24 |
| 00085412010724 | NA | BAXTER HEALTHCARE CORPORATION | KSW | 2016-09-24 |
| 00085412010748 | NA | BAXTER HEALTHCARE CORPORATION | KSW | 2016-09-24 |
| 00085412081908 | NA | BAXTER HEALTHCARE CORPORATION | KSW | 2016-09-24 |
| 00085412081915 | NA | BAXTER HEALTHCARE CORPORATION | KSW | 2016-09-24 |
| 50085412010712 | NA | BAXTER INTERNATIONAL INC. | KSW | 2016-09-24 |
| 50085412010729 | NA | BAXTER INTERNATIONAL INC. | KSW | 2016-09-24 |
| 50085412010743 | NA | BAXTER INTERNATIONAL INC. | KSW | 2016-09-24 |
| 60085412081900 | NA | BAXTER INTERNATIONAL INC. | KSW | 2016-09-24 |
| 50085412081910 | NA | BAXTER INTERNATIONAL INC. | KSW | 2016-09-24 |
| 04086000101271 | Glycerolyte 57 Solution | Fresenius Kabi AG | KSW | 2016-09-02 |
| 04086000101288 | Glycerolyte 57 Solution | Fresenius Kabi AG | KSW | 2016-09-02 |