Endotracheal Tubes

GUDID 00616784455334

DYNAREX CORPORATION

Basic endotracheal tube, single-use Basic endotracheal tube, single-use

• Primary Device ID: 00616784455334
• NIH Device Record Key: 260b83b1-f1bc-40bb-ab2e-41d996a73973
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endotracheal Tubes
• Version Model Number: 4553
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 10
• 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: 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	00616784455310 [Unit of Use]
GS1	00616784455327 [Primary]
GS1	00616784455334 [Package]; Contains: 00616784455327; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042683

FDA Product Code

• BTR: Tube, Tracheal (W/Wo Connector)

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: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Endotracheal Tubes]

• 00616784456638: 4566
• 00616784456539: 4565
• 00616784456430: 4564
• 00616784456331: 4563
• 00616784456225: 4562
• 00616784456133: 4561
• 00616784456034: 4560
• 00616784455938: 4559
• 00616784455839: 4558
• 00616784455730: 4557
• 00616784455631: 4556
• 00616784455532: 4555
• 00616784455433: 4554
• 00616784455334: 4553
• 00616784455235: 4552
• 00616784455136: 4551
• 00616784455037: 4550
• 00616784454931: 4549
• 00616784454832: 4548
• 00616784454733: 4547
• 00616784454634: 4546
• 00616784454535: 4545
• 00616784454436: 4544
• 00616784454337: 4543
• 00616784454238: 4542
• 00616784454122: 4541
• 00616784454030: 4540
• 00616784453934: 4539
• 00616784453835: 4538
• 00616784453736: 4537
• 00616784453637: 4536
• 00616784453538: 4535
• 00616784453439: 4534
• 00616784453330: 4533
• 00616784453231: 4532
• 00616784453132: 4531
• 00616784453033: 4530
• 00840117317314: Endotracheal Tubes, Uncuffed, 2.0 mm