Syringe with fixed needle - For use only with GONA BS-N1A2713U

GUDID 55413206220248

Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600IU/ml FSH

Terumo Europe NV

Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe

• Primary Device ID: 55413206220248
• NIH Device Record Key: f59ff42c-e545-4cd6-b90e-d217ff767179
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Syringe with fixed needle - For use only with GONA
• Version Model Number: BS-N1A2713U
• Catalog Number: BS-N1A2713U
• 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@terumomedica
• 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
• Needle Gauge: 27 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 27 Gauge
• 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: 27 Gauge
• 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: 27 Gauge
• 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: 27 Gauge
• 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: 27 Gauge
• 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: 27 Gauge
• 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: 27 Gauge
• 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: 27 Gauge
• 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: 27 Gauge
• 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: 27 Gauge
• 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: 27 Gauge
• 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: 27 Gauge
• 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: 27 Gauge
• 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: 27 Gauge
• 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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05413206220243 [Primary]
GS1	35413206220244 [Package]; Contains: 05413206220243; Package: Shelf box [100 Units]; In Commercial Distribution
GS1	55413206220248 [Package]; Contains: 35413206220244; Package: Carton [18 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161606

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-26

On-Brand Devices [Syringe with fixed needle - For use only with GONA]

• 55413206220248: Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600IU/ml FSH
• 55413206214209: Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH
• 55413206214162: Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH