Bosma Enterprises

Basic Information

• Brand Name: Bosma Enterprises
• Primary DI: 00818634020765
• Version / Model: 10-8020MU
• Catalog Number: 10-8020MU
• Company Name: Bosma Enterprises
• Labeler DUNS: 878070325
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-02
• Public Version: 1
• Public Version Date: 2021-07-12
• Public Version Status: New
• Public Device Record Key: 0e25f09d-a7a9-48e9-a4f4-1f7193597d67

Device Description

Accelerate-OR Lithotomy Suite MU Kit; Each Kit Includes Lithotomy Suite Kit, 40x40 Clear 2 mil Draw Tape Bag, 40x40 Red Infectious Waste 2 mil Draw Tape Bag, 40x40 Blue 2 mil Draw Tape Bag, and 24x24 Red Liner 1.2 mil 10 gal Bag (2).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PWU	Clean-Up Kit	General Hospital	880.6890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65175	Operating room turnover kit	A collection of devices intended to be used to efficiently clean and prepare an operating room (OR) for a subsequent surgical procedure. It typically includes patient oriented items such as absorbent covers/drapes for the operating table and patient positioners (e.g., headrest), operating room cleaning items such as cleaning mop heads and pads, and refuse containment items such as surgical waste and biohazard bags/buckets. This is a single-use device.	No	Active
62619	Surgical linen/cushion set	A collection of devices intended to be fitted to equipment used to support a patient during surgery (e.g., operating table) to provide a hygienic barrier and positioning/support capabilities. It typically includes operating table sheets, covers, pillows/cushions, foam pads, and equipment drapes. This is a single-use device.	No	Active
12223	Bucket liner	A device used to line a bucket in order to create a barrier to contamination and serve as the basis for preventing cross-contamination, reducing cleaning requirements, and protecting the bucket surface finish. This liner will typically be used in swab buckets, commonly known as kick buckets. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10818634020762	GS1	Case	12	In Commercial Distribution
Primary	00818634020765	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid excessive heat. Keep dry.