HAEMONETICS ACP 215 SYSTEM
- Primary DI
- 10812747015004
- Brand
- HAEMONETICS ACP 215 SYSTEM
- Company
- HAEMONETICS CORPORATION
- Model
- 00225-00
- Device description
- RBC GLYCEROLIZATION SET
- Published
- 2017-02-07
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- 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 |
|---|---|
| BK040077 | 0 |
| BK060008 | 0 |
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| BK040077 | 0 | ||||
| BK060008 | 0 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 30812747015008 | Package | GS1 | 50 | In Commercial Distribution |
| 10812747015004 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 30812747015008 | 30812747015008 |
| 10812747015004 | 10812747015004 |
GMDN Terms#
| Term | Definition |
|---|---|
| Blood cell freeze/thaw system set | A sterile collection of devices intended to be used in a blood cell processing system to either prepare red blood cells for frozen storage (glycerolization), or deglycerolize and wash red blood cells after thawing (may also wash fresh red blood cells). The device typically consists of a bacteriological filter, solution lines, connection ports, and collection containers. This is a single-use device. |
Contacts#
| Phone | |
|---|---|
| +1(800)-537-2802 | pirdesk@Haemonetics.com |
Regulatory Flags#
- DUNS number
- 057827420
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- 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 |
| 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 |
| 30812747015800 | ACP 215 | HAEMONETICS CORPORATION | KSW | 2017-01-31 |
| 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 |