TERUMO

GUDID 54806017511864

TERUMO Needle

TERUMO (PHILIPPINES) CORPORATION

Hypodermic needle, single-use

• Primary Device ID: 54806017511864
• NIH Device Record Key: c06f88ad-f5e3-4683-a086-a6265d9bf504
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TERUMO
• Version Model Number: NN1938R
• Company DUNS: 718848773
• Company Name: TERUMO (PHILIPPINES) CORPORATION
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com

Device Dimensions

• Length: 1.5 Inch
• Length: 1.5 Inch
• Length: 1.5 Inch
• Length: 1.5 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity.

Device Identifiers

Device Issuing Agency	Device ID
GS1	14806017511866 [Unit of Use]
GS1	34806017511860 [Primary]
GS1	54806017511864 [Package]; Contains: 34806017511860; Package: Inner Carton [10 Units]; In Commercial Distribution
GS1	74806017511868 [Package]; Package: Outer Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121607

FDA Product Code

• FMI: Needle, hypodermic, single lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-14

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