K-Pack II KN-2713RBKT50

GUDID 55413206211956

K-Pack II Needle

Terumo Europe NV

Hypodermic needle, single-use

• Primary Device ID: 55413206211956
• NIH Device Record Key: 9b8ed0c7-fc07-4b4f-b6ba-07c2eec54846
• Commercial Distribution Discontinuation: 2018-05-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: K-Pack II
• Version Model Number: KN-2713RBKT50
• Catalog Number: KN-2713RBKT50
• Company DUNS: 370193559
• Company Name: Terumo Europe NV
• Device Count: 1
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05413206211951 [Primary]
GS1	35413206211952 [Package]; Contains: 05413206211951; Package: Shelfbox [50 Units]; Discontinued: 2018-05-07; Not in Commercial Distribution
GS1	55413206211956 [Package]; Contains: 35413206211952; Package: Carton [50 Units]; Discontinued: 2018-05-07; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110850

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: 6
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-05-19

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