HAEMONETICS CELL SAVER 5/5+ SYSTEMS

GUDID 30812747016289

CELL SAVER 5/5+ BOWL KIT-70ML

HAEMONETICS CORPORATION

Red blood cell-recovery autotransfusion system set

Primary Device ID	30812747016289
NIH Device Record Key	e798f215-25b3-4c60-a91e-0017e06d0320
Commercial Distribution Status	In Commercial Distribution
Brand Name	HAEMONETICS CELL SAVER 5/5+ SYSTEMS
Version Model Number	0291E-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	true
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	+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
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	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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10812747016285 [Primary]
GS1	30812747016289 [Package] Contains: 10812747016285 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+ SYSTEMS]

30812747016487	SEQUESTRATION SET
30812747016289	CELL SAVER 5/5+ BOWL KIT-70ML
30812747016142	CS5/5+ FASTPACK, 125ML, 150µ RES
30812747016135	CELL SAVER 5/5+ BOWL KIT-225ML
30812747016128	CELL SAVER 5/5+ BOWL KIT-125ML
30812747016111	CS5/5+ FASTPACK, 225ML 150U RES
30812747016104	10 LITER WASTE BAG