Baleen

Basic Information

• Brand Name: Baleen
• Primary DI: 10816765014391
• Version / Model: NBPT520
• Catalog Number: NBPT520
• Company Name: US Endoscopy
• Labeler DUNS: 627879687
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2018-08-23
• Public Version: 8
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 5a00d775-3d06-4ded-9c75-2bfe4999f0b8
• Distribution End Date: 2020-03-31

Device Description

The Baleen polyp trap is a single use device used in the suction retrieval of endoscopically removed polyps.

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: 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDQ	BOTTLE, COLLECTION, VACUUM	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34858	Surgical suction system collection container, single-use	A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20816765014398	GS1	Box	5	Not in Commercial Distribution	2020-03-31
Primary	10816765014391	GS1
Unit of Use	00816765014394	GS1
Previous	00864390000305	GS1

Customer Contacts

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