Thrombin JMI - 5,000 IU Epistaxis Kit

Basic Information

• Brand Name: Thrombin JMI - 5,000 IU Epistaxis Kit
• Primary DI: 10360793205059
• Version / Model: NDC 60793-205-05
• Company Name: Pfizer H.C.P. Corporation
• Labeler DUNS: 926582081
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-17
• Public Version: 5
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: e89c59df-169b-4798-892c-dd8eef19291b

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

GMDN Terms

Code	Name	Definition	Implantable	Status
44057	General surgical procedure kit, medicated	A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10360793205059	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	10	Milliliter
Device Size Text, specify			Syringe size

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: FALSE
• Type: Storage Environment Temperature
• Temperature Range: 36 – 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius