K-Pack II KN-2908RBKT

GUDID 05413206211050

K-Pack II Needle

Terumo Europe NV

Hypodermic needle, single-use

• Primary Device ID: 05413206211050
• NIH Device Record Key: 1a86f654-ee77-41b3-bbc1-a64d6d44ca5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-Pack II
• Version Model Number: KN-2908RBKT
• Catalog Number: KN-2908RBKT
• 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
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 29 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 29 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 29 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 29 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 29 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 29 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 29 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 29 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 29 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 29 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 29 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 29 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 29 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 29 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 29 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 29 Gauge
• 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.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05413206211050 [Primary]
GS1	55413206211055 [Package]; Package: Carton [5000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151398

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: 2016-09-05

On-Brand Devices [K-Pack II]

• 55413206223683: K-Pack II Needle
• 55413206223645: K-Pack II Needle
• 55413206216739: K-Pack II Needle
• 55413206216722: K-Pack II Needle
• 55413206211956: K-Pack II Needle
• 05413206211418: K-Pack II Needle
• 55413206211130: K-Pack II Needle
• 05413206211050: K-Pack II Needle
• 55413206203647: K-Pack II Needle
• 55413206203555: K-Pack II Needle
• 55413206203548: K-Pack II Needle
• 55413206054553: K-Pack II Needle
• 55413206052672: K-Pack II Needle
• 55413206051040: K-Pack II Needle
• 55413206051033: K-Pack II Needle
• 55413206042314: K-Pack II Needle
• 55413206037082: K-Pack II Needle
• 05413206034338: K-Pack II Needle
• 55413206034326: K-Pack II Needle
• 55413206033206: K-Pack II Needle
• 55413206032667: K-Pack II Needle
• 55413206032650: K-Pack II Needle
• 55413206032643: K-Pack II Needle
• 05413206032037: K-Pack II Needle
• 55413206031868: K-Pack II Needle
• 05413206031771: K-Pack II Needle
• 55413206031745: K-Pack II Needle
• 55413206031318: K-Pack II Needle
• 55413206031165: K-Pack II Needle
• 05413206025053: K-Pack II Needle
• 55413206020541: K-Pack II Needle
• 55413206018142: K-Pack II Needle
• 55413206003810: K-Pack II Needle
• 55413206003803: K-Pack II Needle
• 55413206003797: K-Pack II Needle
• 55413206003780: K-Pack II Needle
• 55413206219174: K-Pack II Needle
• 55413206219167: K-Pack II Needle
• 55413206219150: K-Pack II Needle
• 55413206219136: K-Pack II Needle
• 35413206248217: K-Pack II Needle
• 55413206256537: K-Pack II Needle