Thrombin JMI - 20,000 IU Vial Syringe Spray Kit

Primary DI
10360793217229
Brand
Thrombin JMI - 20,000 IU Vial Syringe Spray Kit
Company
Pfizer H.C.P. Corporation
Model
NDC 60793-217-22
Device description
Thrombin JMI - 20,000 IU Vial Syringe Spray Kit w/20 mL diluent; Contents - Sterile unless tray is opened or damaged: One vial 20,000 units thrombin, one vial 20 mL diluent, one sterile disposable syringe, one sterile spray tip.
Published
2019-04-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10360793217229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1036079321722910360793217229

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various sterile surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume20Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00FALSE
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
926582081
Device count
1
DM exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00360793215051Thrombin JMI 5,000 IU vial and 5 mL diluentNDC 60793-215-052019-04-23
00360793217208Thrombin JMI 20,000 IU vial and 20 mL diluentNDC 60793-217-202019-04-23
10360793217212Thrombin JMI - 20,000 IU Vial Pump spray KitNDC 60793-217-212019-04-23
10360793705054Thrombin JMI - 5,000 IU Vial Syringe Spray KitNDC 60793-705-052019-04-23
10360793205059Thrombin JMI - 5,000 IU Epistaxis KitNDC 60793-205-052019-04-17