Orion II

GUDID 20876604001354

16Ga x 13 cm Single Lumen Orion II CT CVC Kit

Health Line International Corporation

Central venous catheterization kit, short-term

• Primary Device ID: 20876604001354
• NIH Device Record Key: 69b2d8e0-72a2-4864-a61d-545a0d188f77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orion II
• Version Model Number: A33-05113
• Company DUNS: 806251398
• Company Name: Health Line International Corporation
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00876604001350 [Primary]
GS1	10876604001357 [Package]; Contains: 00876604001350; Package: Inner Pack [5 Units]; In Commercial Distribution
GS1	20876604001354 [Package]; Contains: 10876604001357; Package: Case [4 Units]; In Commercial Distribution

FDA Product Code

• FOZ: Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

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: 2018-09-24
• Device Publish Date: 2018-01-30

On-Brand Devices [Orion II]

• 20876604002276: 7Fr x 30 cm Dual Lumen Orion II CT CVC Kit
• 20876604002252: 7Fr x 25 cm Dual Lumen Orion II CT CVC Kit
• 20876604002238: 7Fr x 24 cm Dual Lumen Orion II CT CVC Kit
• 20876604002016: 16Ga x 30 cm Single Lumen Orion II CT CVC Kit
• 20876604001996: 16Ga x 24 cm Single Lumen Orion II CT CVC Kit
• 20876604001729: 7Fr x 16 cm Dual Lumen Orion II CT CVC Kit
• 20876604001699: 7Fr x 13 cm Dual Lumen Orion II CT CVC Kit
• 20876604001583: 16Ga x 20 cm Single Lumen Orion II CT CVC Kit
• 20876604001576: 16Ga x 16 cm Single Lumen Orion II CT CVC Kit
• 20876604001569: 16Ga x 15 cm Single Lumen Orion II CT CVC Kit
• 20876604001408: 7Fr x 20 cm Triple Lumen Orion II CT CVC Kit
• 20876604001392: 7Fr x 15 cm Triple Lumen Orion II CT CVC Kit
• 20876604001385: 7Fr x 20 cm Dual Lumen Orion II CT CVC Kit
• 20876604001354: 16Ga x 13 cm Single Lumen Orion II CT CVC Kit
• 20876604001347: 16 Ga x 10 cm Single Lumen Orion II CT CVC Kit
• 20876604001330: 7Fr x 15 cm Dual Lumen Orion II CT CVC Kit