Bosma Enterprises

Basic Information

• Brand Name: Bosma Enterprises
• Primary DI: 00818634020420
• Version / Model: 10-8020CT
• Catalog Number: 10-8020CT
• 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: 2
• Public Version Date: 2022-07-04
• Public Version Status: Update
• Public Device Record Key: 9f910580-75fd-4a84-a7c6-97ae21941c19

Device Description

Accelerate-OR CT Kit; Each Kit Includes QuickSuite Kit, 20x29 Disposable Pillowcase, and Disposable Washcloth (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
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
47454	Basic pillowcase, single-use	A protective envelope for a pillow typically made of a thin-textile or reinforced-paper material intended to create a physical barrier to soiling and cross-contamination. It does not include antimicrobial/probiotic materials but might provide a physical barrier (e.g., tight weave) to dust mites. This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10818634020427	GS1	Case	12	In Commercial Distribution
Primary	00818634020420	GS1

Customer Contacts

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

Storage Conditions

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