HAEMONETICS ACP 215 SYSTEM

GUDID 30812747015022

RBC DE-GLYCEROL. SET 325ML BMB

HAEMONETICS CORPORATION

Blood cell freeze/thaw system set
Primary Device ID30812747015022
NIH Device Record Keycc724c0e-ea97-4aee-b638-a9fcd778668f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAEMONETICS ACP 215 SYSTEM
Version Model Number00236-00
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com

Device Dimensions

Total Volume5 Liter
Total Volume325 Milliliter
Total Volume600 Milliliter
Total Volume5 Liter
Total Volume325 Milliliter
Total Volume600 Milliliter
Total Volume5 Liter
Total Volume325 Milliliter
Total Volume600 Milliliter
Total Volume5 Liter
Total Volume325 Milliliter
Total Volume600 Milliliter
Total Volume5 Liter
Total Volume325 Milliliter
Total Volume600 Milliliter
Total Volume5 Liter
Total Volume325 Milliliter
Total Volume600 Milliliter
Total Volume5 Liter
Total Volume325 Milliliter
Total Volume600 Milliliter
Total Volume5 Liter
Total Volume325 Milliliter
Total Volume600 Milliliter
Total Volume5 Liter
Total Volume325 Milliliter
Total Volume600 Milliliter
Total Volume5 Liter
Total Volume325 Milliliter
Total Volume600 Milliliter
Total Volume5 Liter
Total Volume325 Milliliter
Total Volume600 Milliliter
Total Volume5 Liter
Total Volume325 Milliliter
Total Volume600 Milliliter
Total Volume5 Liter
Total Volume325 Milliliter
Total Volume600 Milliliter
Total Volume5 Liter
Total Volume325 Milliliter
Total Volume600 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS110812747015028 [Primary]
GS130812747015022 [Package]
Contains: 10812747015028
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSWSYSTEM, PROCESSING FOR FROZEN BLOOD

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-10-19
Device Publish Date2017-02-07

On-Brand Devices [HAEMONETICS ACP 215 SYSTEM]

30812747015022RBC DE-GLYCEROL. SET 325ML BMB
30812747015015RBC DE-GLYCEROL./CELL WASH SET
30812747015008RBC GLYCEROLIZATION SET

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.