Cook

Basic Information

• Brand Name: Cook
• Primary DI: 00827002105546
• Version / Model: G10554
• Catalog Number: C-RETRO-14.0-70-38J-110-CAE
• Company Name: COOK INCORPORATED
• Labeler DUNS: 042823948
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: e7492c46-bfd3-4260-b325-70fa6dfe9076

Device Description

Cook Retrograde Intubation Set

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KTI	BRONCHOSCOPE ACCESSORY	Ear, Nose, Throat	874.4680	2

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	00827002105546	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dark, dry, cool place.