ACP 215

GUDID 30812747015183

UNIT PACK ASSY,SHAKER,ACP215

HAEMONETICS CORPORATION

Blood cell freeze/thaw system
Primary Device ID30812747015183
NIH Device Record Keye364843e-6c11-4376-9bbc-40139074dbc3
Commercial Distribution StatusIn Commercial Distribution
Brand NameACP 215
Version Model Number50042-00
Company DUNS057827420
Company NameHAEMONETICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS130812747015183 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSWSYSTEM, PROCESSING FOR FROZEN BLOOD

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-05-02

On-Brand Devices [ACP 215]

30812747015817ACP215, 220V, LN 02215-220-E
30812747015800ACP215, 110V, LN 02215-110-E
30812747015183UNIT PACK ASSY,SHAKER,ACP215

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