Thrombin JMI 20,000 IU vial and 20 mL diluent

Primary DI
00360793217208
Brand
Thrombin JMI 20,000 IU vial and 20 mL diluent
Company
Pfizer H.C.P. Corporation
Model
NDC 60793-217-20
Device description
Thrombin JMI 20,000 IU vial and 20 mL diluent with transfer device; A topical hemostat for application to the surface of bleeding tissues. See package insert for complete directions.
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
00360793217208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00360793217208003607932172083607932172080360793217208

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
Radiation Sterilization

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
10360793217212Thrombin JMI - 20,000 IU Vial Pump spray KitNDC 60793-217-212019-04-23
10360793217229Thrombin JMI - 20,000 IU Vial Syringe Spray KitNDC 60793-217-222019-04-23
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