MIXJECT

GUDID 27290108241062

MIXJECT 13mm w/27G Needle

WEST PHARMA. SERVICES IL, . LTD

Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set

• Primary Device ID: 27290108241062
• NIH Device Record Key: a69df231-0444-4fbd-b495-c00c349d6abc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIXJECT
• Version Model Number: 9070126
• 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	07290108241068 [Primary]
GS1	17290108241065 [Package]; Contains: 07290108241068; Package: [150 Units]; In Commercial Distribution
GS1	27290108241062 [Package]; Contains: 17290108241065; 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

[27290108241062]

Radiation Sterilization

[27290108241062]

Radiation Sterilization

[27290108241062]

Radiation Sterilization

[27290108241062]

Radiation Sterilization

[27290108241062]

Radiation Sterilization

[27290108241062]

Radiation Sterilization

[27290108241062]

Radiation Sterilization

[27290108241062]

Radiation Sterilization

[27290108241062]

Radiation Sterilization

[27290108241062]

Radiation Sterilization

[27290108241062]

Radiation Sterilization

[27290108241062]

Radiation Sterilization

[27290108241062]

Radiation Sterilization

[27290108241062]

Radiation Sterilization

[27290108241062]

Radiation Sterilization

[27290108241062]

Radiation Sterilization

[27290108241062]

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