TERUMO

Basic Information

• Brand Name: TERUMO
• Primary DI: 34806017511044
• Version / Model: SS-01T2325
• Company Name: TERUMO (PHILIPPINES) CORPORATION
• Labeler DUNS: 718848773
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-02
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 949b08fa-8358-49a2-8fed-043e3b1d34b1

Device Description

TERUMO Tuberculin Syringe

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMF	Syringe, piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35904	Metered-delivery hypodermic syringe	A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	54806017511048	GS1	Carton	10	In Commercial Distribution
Primary	34806017511044	GS1
Unit of Use	14806017511040	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K052034	000

Device Sizes

Type	Value	Unit	Text
Length	1	Inch
Total Volume	1	Milliliter
Needle Gauge	23	Gauge

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Fragile. Handle with care. Keep dry. Keep away from sunlight.
• Type: Special Storage Condition, Specify
• Special Conditions: Do not store at extreme temperature and humidity