Display Control Unit Sheath AVA 500 DCOV

GUDID 40616258024866

SHEATH,DISPLAY CONTROL UNIT,MC,CORE (87640515)

Bayer Medical Care Inc.

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Primary Device ID	40616258024866
NIH Device Record Key	db5d5dd9-a9ef-49c8-acc0-76a0533ac8f0
Commercial Distribution Status	In Commercial Distribution
Brand Name	Display Control Unit Sheath
Version Model Number	AVA 500 DCOV
Catalog Number	AVA 500 DCOV
Company DUNS	049673973
Company Name	Bayer Medical Care Inc.
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	false
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	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1 800-633-7231
Email	ricustomercomplaints@bayer.com
Phone	+1 800-633-7231
Email	ricustomercomplaints@bayer.com
Phone	+1 800-633-7231
Email	ricustomercomplaints@bayer.com
Phone	+1 800-633-7231
Email	ricustomercomplaints@bayer.com
Phone	+1 800-633-7231
Email	ricustomercomplaints@bayer.com
Phone	+1 800-633-7231
Email	ricustomercomplaints@bayer.com
Phone	+1 800-633-7231
Email	ricustomercomplaints@bayer.com
Phone	+1 800-633-7231
Email	ricustomercomplaints@bayer.com
Phone	+1 800-633-7231
Email	ricustomercomplaints@bayer.com
Phone	+1 800-633-7231
Email	ricustomercomplaints@bayer.com
Phone	+1 800-633-7231
Email	ricustomercomplaints@bayer.com
Phone	+1 800-633-7231
Email	ricustomercomplaints@bayer.com
Phone	+1 800-633-7231
Email	ricustomercomplaints@bayer.com
Phone	+1 800-633-7231
Email	ricustomercomplaints@bayer.com
Phone	+1 800-633-7231
Email	ricustomercomplaints@bayer.com
Phone	+1 800-633-7231
Email	ricustomercomplaints@bayer.com
Phone	+1 800-633-7231
Email	ricustomercomplaints@bayer.com

Operating and Storage Conditions

Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258024868 [Primary]
GS1	40616258024866 [Package] Contains: 00616258024868 Package: Box [25 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K050456

FDA Product Code

DXT	Injector And Syringe, Angiographic

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-05-14
Device Publish Date	2024-05-06

On-Brand Devices [Display Control Unit Sheath]

00616258007557	Avanta Single Use Display Control Unit Sheath (SHEATH, DISPLAY CONTROL UNIT, MC, LA) (60728583)
10616258007189	Avanta Single Use Display Control Unit Sheath (SHEATH, DISPLAY CONTROL UNIT,MC,JA) (84194875)
00616258005355	Avanta Single Use Display Control Unit Sheath (ANGIO - AVANTA, SHEATH, DCU, MC) (60729563)
40616258010234	Avanta Single Use Display Control Unit Sheath(SHEATH, DISPLAY CONTROL UNIT,MC,JA2)(85231472)
40616258021551	SHEATH,DISPLAY CONTROL UNIT,MC,WLD (86566737)
40616258024866	SHEATH,DISPLAY CONTROL UNIT,MC,CORE (87640515)