Thrombin JMI 5,000 IU vial and 5 mL diluent

GUDID 00360793215051

Thrombin JMI 5,000 IU vial and 5 mL diluent with transfer device; A topical hemostat for application to the surface of bleeding tissues. See package insert for complete directions.

PFIZER INC.

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Primary Device ID	00360793215051
NIH Device Record Key	d33dd128-ede1-4e1c-be76-e202b02d920f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Thrombin JMI 5,000 IU vial and 5 mL diluent
Version Model Number	NDC 60793-215-05
Company DUNS	829076566
Company Name	PFIZER INC.
Device Count	1
DM Exempt	true
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	true
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	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(484)865-6166
Email	Karena.Arrenon@pfizer.com
Phone	+1(484)865-6166
Email	Karena.Arrenon@pfizer.com
Phone	+1(484)865-6166
Email	Karena.Arrenon@pfizer.com
Phone	+1(484)865-6166
Email	Karena.Arrenon@pfizer.com
Phone	+1(484)865-6166
Email	Karena.Arrenon@pfizer.com
Phone	+1(484)865-6166
Email	Karena.Arrenon@pfizer.com
Phone	+1(484)865-6166
Email	Karena.Arrenon@pfizer.com
Phone	+1(484)865-6166
Email	Karena.Arrenon@pfizer.com
Phone	+1(484)865-6166
Email	Karena.Arrenon@pfizer.com
Phone	+1(484)865-6166
Email	Karena.Arrenon@pfizer.com
Phone	+1(484)865-6166
Email	UDICompliance@pfizer.com
Phone	+1(484)865-6166
Email	UDICompliance@pfizer.com
Phone	+1(484)865-6166
Email	UDICompliance@pfizer.com
Phone	+1(484)865-6166
Email	UDICompliance@pfizer.com
Phone	+1(484)865-6166
Email	UDICompliance@pfizer.com
Phone	+1(484)865-6166
Email	UDICompliance@pfizer.com
Phone	+1(484)865-6166
Email	UDICompliance@pfizer.com
Phone	+1(484)865-6166
Email	UDICompliance@pfizer.com
Phone	+1(484)865-6166
Email	UDICompliance@pfizer.com
Phone	+1(484)865-6166
Email	UDICompliance@pfizer.com
Phone	+1(484)865-6166
Email	UDICompliance@pfizer.com
Phone	+1(484)865-6166
Email	UDICompliance@pfizer.com
Phone	+1(484)865-6166
Email	UDICompliance@pfizer.com
Phone	+1(484)865-6166
Email	UDICompliance@pfizer.com
Phone	+1(484)865-6166
Email	UDICompliance@pfizer.com
Phone	+1(484)865-6166
Email	UDICompliance@pfizer.com
Phone	+1(484)865-6166
Email	UDICompliance@pfizer.com
Phone	+1(484)865-6166
Email	UDICompliance@pfizer.com
Phone	+1(484)865-6166
Email	UDICompliance@pfizer.com

Device Dimensions

Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *FALSE
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *FALSE
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00360793215051 [Primary]

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

[00360793215051]

Radiation Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-05-01
Device Publish Date	2019-04-23

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