MIXJECT

GUDID 27290108241017

MIXJECT™ 13mm w/27G Needle

WEST PHARMA. SERVICES IL, . LTD

Medication transfer set

• Primary Device ID: 27290108241017
• NIH Device Record Key: d5c9ab64-2def-417b-9754-735333581d28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIXJECT
• Version Model Number: 970113
• Company DUNS: 600267793
• Company Name: WEST PHARMA. SERVICES IL, . LTD
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290108241013 [Primary]
GS1	17290108241010 [Package]; Contains: 07290108241013; Package: [150 Units]; In Commercial Distribution
GS1	27290108241017 [Package]; Contains: 17290108241010; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963583

FDA Product Code

• LHI: Set, I.V. Fluid Transfer

Sterilization

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

[27290108241017]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-18
• Device Publish Date: 2016-05-01

On-Brand Devices [MIXJECT]

• 27290108241062: MIXJECT 13mm w/27G Needle
• 27290108241055: Needleless Mixject 13mm SIL
• 27290108241048: Mixject 13mm SIL w/30G Needle
• 27290108241031: Mixject 13mm w/30G needle T/N
• 27290108241017: MIXJECT™ 13mm w/27G Needle
• 27290108240966: MIXJECT™ 13mm w/27G Needle (Mixject Transfer Device)
• 27290108240942: Mixject 20mm W/21G safety needle
• 27290108240836: MIXJECT™ 20mm w/20G x 1½" Needle