Biomedix B37 SELEC-3+NIS+LAS IV ADM. SET

GUDID 00851470007088

B37 SELEC-3+NIS+LAS IV ADM. SET

BIOMEDIX-INC

Intravenous administration tubing extension set

• Primary Device ID: 00851470007088
• NIH Device Record Key: ebac06da-5f54-4383-b58a-d840c1488e35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biomedix B37 SELEC-3+NIS+LAS IV ADM. SET
• Version Model Number: B37-102
• Company DUNS: 798045530
• Company Name: BIOMEDIX-INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851470007088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142097

FDA Product Code

• LHI: Set, I.V. Fluid Transfer

Sterilization

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

[00851470007088]

Radiation Sterilization

[00851470007088]

Radiation Sterilization

[00851470007088]

Radiation Sterilization

[00851470007088]

Radiation Sterilization

[00851470007088]

Radiation Sterilization

[00851470007088]

Radiation Sterilization

[00851470007088]

Radiation Sterilization

[00851470007088]

Radiation Sterilization

[00851470007088]

Radiation Sterilization

[00851470007088]

Radiation Sterilization

[00851470007088]

Radiation Sterilization

[00851470007088]

Radiation Sterilization

[00851470007088]

Radiation Sterilization

[00851470007088]

Radiation Sterilization

[00851470007088]

Radiation Sterilization

[00851470007088]

Radiation Sterilization

[00851470007088]

Radiation Sterilization

[00851470007088]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-19

Devices Manufactured by BIOMEDIX-INC

• 00851470007002 - Biomedix B10 SELEC-3 IV ADM. SET: 2018-03-29 B10 SELEC-3 IV ADM. SET
• 00851470007019 - Biomedix B11 SELEC-3+SC IV ADM. SET: 2018-03-29 B11 SELEC-3+SC IV ADM. SET
• 00851470007026 - Biomedix B12 SELEC-3+NIS IV ADM. SET: 2018-03-29 B12 SELEC-3+NIS IV ADM. SET
• 00851470007033 - Biomedix B15 SELEC-3+SC+NIS IV ADM. SET: 2018-03-29 B15 SELEC-3+SC+NIS IV ADM. SET
• 00851470007040 - Biomedix B30 SELEC-3+NIS+LAS IV ADM. SET: 2018-03-29 B30 SELEC-3+NIS+LAS IV ADM. SET
• 00851470007057 - Biomedix B31 SELEC-3+NIS+LAS IV ADM. SET: 2018-03-29 B31 SELEC-3+NIS+LAS IV ADM. SET
• 00851470007064 - Biomedix B32 SELEC-3+NIS+LAS IV ADM. SET: 2018-03-29 B32 SELEC-3+NIS+LAS IV ADM. SET
• 00851470007071 - Biomedix B36 SELEC-3+LAS IV ADM. SET: 2018-03-29 B36 SELEC-3+LAS IV ADM. SET