TERUMO

Basic Information

• Brand Name: TERUMO
• Primary DI: 14806017509436
• Version / Model: SS+30L1
• Company Name: TERUMO (PHILIPPINES) CORPORATION
• Labeler DUNS: 718848773
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-27
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 2c8bbba3-e4df-4b34-a8bd-29c4d3da1c03

Device Description

TERUMO Syringes without Needle

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	54806017509434	GS1	Carton	8	In Commercial Distribution
Primary	14806017509436	GS1
Package	34806017509430	GS1	Shelfbox	25	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K063613	000

Device Sizes

Type	Value	Unit	Text
Total Volume	30	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not store at extreme temperature and humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Fragile. Handle with care. Keep dry. Keep away from sunlight. Stacking limit by 4.