H.E.L.P.® 4469

GUDID 04046964156731

H.E.L.P. ACETATPUFFER HOT US / CA

B.Braun Avitum AG

Apheresis kit

Primary Device ID	04046964156731
NIH Device Record Key	5da7c8fd-dd20-40a3-a554-6336e3972547
Commercial Distribution Status	In Commercial Distribution
Brand Name	H.E.L.P.®
Version Model Number	4469
Catalog Number	4469
Company DUNS	343689704
Company Name	B.Braun Avitum AG
Device Count	2
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
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	+1(800)227-2862
Email	BBMUS_Service.EmailOrders@bbraun.com
Phone	+1(800)227-2862
Email	BBMUS_Service.EmailOrders@bbraun.com
Phone	+1(800)227-2862
Email	BBMUS_Service.EmailOrders@bbraun.com
Phone	+1(800)227-2862
Email	BBMUS_Service.EmailOrders@bbraun.com
Phone	+1(800)227-2862
Email	BBMUS_Service.EmailOrders@bbraun.com
Phone	+1(800)227-2862
Email	BBMUS_Service.EmailOrders@bbraun.com
Phone	+1(800)227-2862
Email	BBMUS_Service.EmailOrders@bbraun.com
Phone	+1(800)227-2862
Email	BBMUS_Service.EmailOrders@bbraun.com
Phone	+1(800)227-2862
Email	BBMUS_Service.EmailOrders@bbraun.com
Phone	+1(800)227-2862
Email	BBMUS_Service.EmailOrders@bbraun.com
Phone	+1(800)227-2862
Email	BBMUS_Service.EmailOrders@bbraun.com
Phone	+1(800)227-2862
Email	BBMUS_Service.EmailOrders@bbraun.com
Phone	+1(800)227-2862
Email	BBMUS_Service.EmailOrders@bbraun.com
Phone	+1(800)227-2862
Email	BBMUS_Service.EmailOrders@bbraun.com
Phone	+1(800)227-2862
Email	BBMUS_Service.EmailOrders@bbraun.com
Phone	+1(800)227-2862
Email	BBMUS_Service.EmailOrders@bbraun.com
Phone	+1(800)227-2862
Email	BBMUS_Service.EmailOrders@bbraun.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046964156724 [Unit of Use]
GS1	04046964156731 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P940016

FDA Product Code

MMY	LIPOPROTEIN, LOW DENSITY, REMOVAL

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	2019-04-29
Device Publish Date	2016-03-09

On-Brand Devices [H.E.L.P.®]

04046964699467	HELP HEPARIN 400,000 IU V 50/40ML US
04046964696770	HELP ULTRAFILTER HIPS 20 US
04046964695865	HELP HOT FUTURA SET US
04046964156731	H.E.L.P. ACETATPUFFER HOT US / CA

Trademark Results [H.E.L.P.]

Mark Image Registration \| Serial	Company Trademark Application Date
H.E.L.P. 90514146 not registered Live/Pending	OMEX AGRIFLUIDS, INC. 2021-02-05
H.E.L.P. 90092672 not registered Live/Pending	Hyperfocus Services LLC 2020-08-04
H.E.L.P. 88100946 not registered Live/Pending	David M. Tucker 2018-08-31
H.E.L.P. 86717974 not registered Dead/Abandoned	HOME ENERGY CONSERVATION, LLC 2015-08-07
H.E.L.P. 86165614 4588378 Live/Registered	Hardiesty, Jacqulyne Patricia 2014-01-14
H.E.L.P. 85024475 4035839 Live/Registered	Salix Pharmaceuticals, Ltd. 2010-04-27
H.E.L.P. 78644863 not registered Dead/Abandoned	Pierre C. Bass 2005-06-07
H.E.L.P. 78388317 not registered Dead/Abandoned	Solis Property Solutions 2004-03-22
H.E.L.P. 77711941 3929136 Live/Registered	Robert J. Logston 2009-04-10
H.E.L.P. 77417728 3720594 Live/Registered	The Legal Coverage Group, Ltd. 2008-03-10
H.E.L.P. 76976215 2903093 Live/Registered	B. BRAUN AVITUM AG 2001-10-12
H.E.L.P. 76506017 3008182 Live/Registered	Healthcare and Elder Law Programs Corporation 2003-04-14