Cardioplegia Plus
GUDID 30887691000301
Filters with Solution Spike
HAEMONETICS CORPORATION
Blood donor set, single-pack| Primary Device ID | 30887691000301 |
| NIH Device Record Key | 5fcd5b7e-6fff-47d9-a7cf-c9b0c67f74ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cardioplegia Plus |
| Version Model Number | CPS02 |
| Company DUNS | 057827420 |
| Company Name | HAEMONETICS CORPORATION |
| Device Count | 1 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10887691000307 [Primary] |
| GS1 | 30887691000301 [Package] Contains: 10887691000307 Package: [40 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K875095
FDA Product Code
| JOD | FILTER, BLOOD, CARDIOTOMY SUCTION LINE, CARDIOPULMONARY BYPASS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-01-19 |
Devices Manufactured by HAEMONETICS CORPORATION
| 20812747018538 - Global Hemostasis - HN | 2024-04-18 CITRATED: K, KH, RTH, FFH |
| 30812747013516 - MCS+ (LN8150) RBC APHERESIS | 2023-10-19 2 UNIT RED CELL SET W/RC2H FIL |
| 30812747015008 - HAEMONETICS ACP 215 SYSTEM | 2023-10-19 RBC GLYCEROLIZATION SET |
| 30812747015015 - HAEMONETICS ACP 215 SYSTEM | 2023-10-19 RBC DE-GLYCEROL./CELL WASH SET |
| 30812747015022 - HAEMONETICS ACP 215 SYSTEM | 2023-10-19 RBC DE-GLYCEROL. SET 325ML BMB |
| 10812747018043 - TEG HEMOSTASIS SYSTEM | 2023-10-10 CALCIUM CHLORIDE, 0.2M, 5 ML |
| 30812747019334 - Haemonetics® NexSys PCS® System | 2023-07-07 0625Q-00 Plasma Bowl |
| 30812747012861 - MCS 9000 | 2023-02-15 |
Trademark Results [Cardioplegia Plus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARDIOPLEGIA PLUS 73541494 1379038 Live/Registered |
PALL CORPORATION 1985-06-05 |
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