HAEMONETICS CELL SAVER 5/5+ SYSTEM

GUDID 10812747015172

CELL SAVER 5/5+ BOWL SET (70ML)

HAEMONETICS CORPORATION

Red blood cell-recovery autotransfusion system

Primary Device ID	10812747015172
NIH Device Record Key	a3e94c98-4441-4ade-8028-bfcc5c0e18b6
Commercial Distribution Status	In Commercial Distribution
Brand Name	HAEMONETICS CELL SAVER 5/5+ SYSTEM
Version Model Number	0291A-00
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	true
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	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter
Total Volume	1000 Milliliter
Total Volume	5 Liter
Total Volume	70 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10812747015172 [Primary]
GS1	30812747015176 [Package] Package: Carton [8 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K014083

FDA Product Code

CAC	Apparatus, Autotransfusion

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2021-01-08
Device Publish Date	2015-09-24

On-Brand Devices [HAEMONETICS CELL SAVER 5/5+ SYSTEM]

30812747016272	CS5/5+ FASTPACK, 125ML 20µ RES
30812747016265	CS5/5+ FASTPACK,225ML, 20µ RES
10812747015172	CELL SAVER 5/5+ BOWL SET (70ML)
30812747015169	HIGH SPEED CELL SAVER5/5+BOWL SET