MedSource Intubation Kit

Basic Information

• Brand Name: MedSource Intubation Kit
• Primary DI: 00840155407459
• Version / Model: MS-B3351
• Catalog Number: Not Applicable
• Company Name: MEDSOURCE INTERNATIONAL LLC
• Labeler DUNS: 041674552
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-28
• Public Version: 1
• Public Version Date: 2021-08-05
• Public Version Status: New
• Public Device Record Key: 88b8cc81-ead2-484a-9f31-c84524dd8ed9

Device Description

Intubation Kit Bag, Padded, Navy

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
46972	Retrograde endotracheal intubation kit	A collection of sterile devices used to assist in the placement of an endotracheal (ET) tube during difficult/emergency airway access procedures. The device typically consists of a guidewire, needles, and a needle holder made of metal, and catheters and adaptors made of plastic materials. Initial percutaneous access is achieved using the Seldinger technique via the cricothyroid membrane, permitting retrograde (cephalad directed) placement of the guidewire which exits orally or nasally. Antegrade introduction down the guidewire of a hollow guiding catheter with distal sideports allows patient oxygenation and facilitates the placement of the ET tube. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840155407459	GS1