Thrombin JMI - 5,000 IU Epistaxis Kit

GUDID 10360793205059

Thrombin JMI - 5,000 IU Epistaxis Kit w/5 mL diluent; Contents - Sterile unless tray is opened or damaged: one vial 5,000 units thrombin, one vial 5 mL diluent, one sterile disposable syringe, one nasal drug delivery device

PFIZER INC.

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Primary Device ID10360793205059
NIH Device Record Keye89c59df-169b-4798-892c-dd8eef19291b
Commercial Distribution StatusIn Commercial Distribution
Brand NameThrombin JMI - 5,000 IU Epistaxis Kit
Version Model NumberNDC 60793-205-05
Company DUNS829076566
Company NamePFIZER INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(484)865-6166
EmailKarena.Arrenon@pfizer.com
Phone+1(484)865-6166
EmailKarena.Arrenon@pfizer.com
Phone+1(484)865-6166
EmailKarena.Arrenon@pfizer.com
Phone+1(484)865-6166
EmailKarena.Arrenon@pfizer.com
Phone+1(484)865-6166
EmailKarena.Arrenon@pfizer.com
Phone+1(484)865-6166
EmailKarena.Arrenon@pfizer.com
Phone+1(484)865-6166
EmailKarena.Arrenon@pfizer.com
Phone+1(484)865-6166
EmailKarena.Arrenon@pfizer.com
Phone+1(484)865-6166
EmailKarena.Arrenon@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com

Device Dimensions

Device Size Text, specify0
Total Volume10 Milliliter
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Total Volume10 Milliliter
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Total Volume10 Milliliter
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Total Volume10 Milliliter
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Total Volume10 Milliliter
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Total Volume10 Milliliter
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Total Volume10 Milliliter
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Total Volume10 Milliliter
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Total Volume10 Milliliter
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Total Volume10 Milliliter
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Total Volume10 Milliliter
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Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
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Total Volume10 Milliliter
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Total Volume10 Milliliter
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110360793205059 [Primary]

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


[10360793205059]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-25
Device Publish Date2019-04-17

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