Set, Administration, Intravascular

GUDID 00858641006116

LIFE SCIENCE OUTSOURCING, INC.

Medication transfer set

• Primary Device ID: 00858641006116
• NIH Device Record Key: cd8ed810-56a4-4050-949a-5376ca73f6a5
• Commercial Distribution Discontinuation: 2020-02-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Set, Administration, Intravascular
• Version Model Number: DD-001-14
• Company DUNS: 017149456
• Company Name: LIFE SCIENCE OUTSOURCING, INC.
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858641006116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982587

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2020-02-10
• Device Publish Date: 2016-05-03

On-Brand Devices [Set, Administration, Intravascular]

• 00858641006208: EB-060-26
• 00858641006192: SM-016
• 00858641006185: SM-013
• 00858641006178: FS-175B
• 00858641006161: FL1002-FM
• 00858641006154: FL1000-FM
• 00858641006147: EI-060-20
• 00858641006130: EB-060-02
• 00858641006116: DD-001-14
• 00858641006109: DC-012-01
• 00858641006093: DC-006-01
• 00858641006079: 19TP
• 00858641006062: 19MPT