DEVICE: ACP 215 (30812747015183)
Device Identifier (DI) Information
ACP 215
50042-00
In Commercial Distribution
HAEMONETICS CORPORATION
50042-00
In Commercial Distribution
HAEMONETICS CORPORATION
UNIT PACK ASSY,SHAKER,ACP215
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
45519 | 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KSW | SYSTEM, PROCESSING FOR FROZEN BLOOD |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
BK060008 | 0 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e364843e-6c11-4376-9bbc-40139074dbc3
July 06, 2018
3
May 02, 2017
July 06, 2018
3
May 02, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)-537-2802
pirdesk@Haemonetics.com
pirdesk@Haemonetics.com