Swabbable Valve Transfer Set SVTS

GUDID 40616258024552

ASSY,TBG,SWAB VALV,TNSFR SET,MC,CORE (87622584)

Bayer Medical Care Inc.

Fluid transfer set, general-purpose

Primary Device ID	40616258024552
NIH Device Record Key	1d8c0ee8-2361-4e82-bf4e-29c48ca3b5d2
Commercial Distribution Status	In Commercial Distribution
Brand Name	Swabbable Valve Transfer Set
Version Model Number	SVTS
Catalog Number	SVTS
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	false
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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258024554 [Primary]
GS1	40616258024552 [Package] Contains: 00616258024554 Package: Box [50 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K031808

FDA Product Code

FPK	Tubing, Fluid Delivery

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

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40616258024309 - Disposable MRI Kit with Check Valve	2024-05-14 SPECTRIS,KIT,SYR,MRI,65ML,CHK,MC,CORE (87622444)
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