CALCIUM CHLORIDE 5 ML Medical Device Identification

GUDID 00885074184937

CALCIUM CHLORIDE 5 ML

MEDTRONIC, INC.

Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control

Primary Device ID	00885074184937
NIH Device Record Key	63e38ca8-9941-4bbc-84b5-fde6f33da3f2
Commercial Distribution Status	In Commercial Distribution
Version Model Number	550-11
Company DUNS	006261481
Company Name	MEDTRONIC, 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	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	5 Milliliter
Device Size Text, specify	0

Operating and Storage Conditions

Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885074184937 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K880302

FDA Product Code

GGN	PLASMA, COAGULATION CONTROL

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-05-02

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