TrueCare Biomedix

GUDID 10850789007137

Truecare Biomedix - USA

Intravenous administration set

• Primary Device ID: 10850789007137
• NIH Device Record Key: d03989cb-bddb-42b9-9d4c-8f6b7a50fc31
• Commercial Distribution Discontinuation: 2020-02-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TrueCare Biomedix
• Version Model Number: TCBSYR3B
• Company DUNS: 005457284
• Company Name: Truecare Biomedix - USA
• Device Count: 200
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850789007130 [Unit of Use]
GS1	10850789007137 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083686

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

[10850789007137]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-20
• Device Publish Date: 2018-01-09

On-Brand Devices [TrueCare Biomedix]

• 30850789007032: TCBINF044G
• 20850789007349: TCBPTTH-2LL
• 20850789007318: TCBINF6419
• 20850789007301: TCBEXT004
• 20850789007295: TCBEXT003
• 20850789007288: TCBEXT001
• 20850789007271: TCBPTT331
• 20850789007264: TCBPTT063
• 20850789007257: TCBPTT062
• 20850789007240: TCBPTT013S
• 20850789007233: TCBPTT021
• 20850789007226: TCBPTTPS1
• 20850789007219: TCBPTT001
• 20850789007202: TCBSYR60L-30
• 20850789007196: TCBSYR60C-30
• 20850789007103: TCBINF6481
• 20850789007097: TCBINF6571
• 20850789007080: TCBINF6537
• 20850789007073: TCBINF6480
• 20850789007066: TCBINF6519
• 20850789007059: TCBINF6200
• 20850789007042: TCBINF621
• 20850789007035: TCBINF044G
• 20850789007028: TCBINF033G
• 20850789007011: TCBINF022AE
• 20850789007004: TCBINF001
• 10850789007342: TCBPTTH-2LL
• 10850789007335: TCBSYR20B
• 10850789007328: TCBSYR10B
• 10850789007311: TCBINF6419
• 10850789007304: TCBEXT004
• 10850789007298: TCBEXT003
• 10850789007281: TCBEXT001
• 10850789007274: TCBPTT331
• 10850789007267: TCBPTT063
• 10850789007250: TCBPTT062
• 10850789007243: TCBPTT013S
• 10850789007229: TCBPTTPS1
• 10850789007212: TCBPTT001
• 10850789007205: TCBSYR60L-30
• 10850789007199: TCBSYR60C-30
• 10850789007137: TCBSYR3B
• 10850789007106: TCBINF6481
• 10850789007090: TCBINF6571
• 10850789007083: TCBINF6537
• 10850789007076: TCBINF6480
• 10850789007069: TCBINF6519
• 10850789007052: TCBINF6200
• 10850789007045: TCBINF621
• 10850789007021: TCBINF033G