Bosma Enterprises

Basic Information

• Brand Name: Bosma Enterprises
• Primary DI: 00818634020864
• Version / Model: 10-7010
• Catalog Number: 10-7010
• 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: 6fbebd88-bd04-4768-86e1-d5b157ff367e

Device Description

Shelter in Place Kit; Each Kit Includes 40x80 Disposable Grey Poly Blanket, 40x60 Disposable White Rayon Sheet, 13x17 Disposable Pillow, Terry Washcloth (2), 22x44 White Terry Bath Towel, 2 oz Hand Sanitizer, .85 oz Toothpaste, .64 oz Deodorant Soap, Plastic Soap Dish, and Toothbrush.

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
NXZ	Dental Hygiene Kit	Dental	872.6855	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47447	Bed blanket, single-use	A large piece of fabric or fabric-like material used to cover a patient/person to insulate body heat for warmth. It is typically used as a bed covering, but may be used for other purposes (e.g., as a wrap for warmth and comfort). This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).	No	Active
47456	Basic bed sheet, single-use	A large piece of fabric material intended to cover the mattress of a bed to protect it from being soiled and to provide the bed's occupant with clean, non-irritating contact surfaces (over and under); it does not include antimicrobial or nonadherent properties. It is typically made of a thin-textile or reinforced-paper material. This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).	No	Active
47452	Bed pillow, single-use	A sealed cloth case stuffed with soft material (e.g., foam rubber) designed to support the head especially during rest and sleep in bed; it can also be used to support another part of the body to provide comfort (e.g., behind the back when in a sitting position, under a leg for support). It may or may not be used with a pillowcase. 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
41471	Bar skin soap	A cleansing agent designed for washing the skin, often the hands but also the rest of the body, in the form of a fatty compound compressed into a block shape that can be delivered in bulk and individually wrapped or loaded into a dispenser.	No	Active
31817	Basic manual toothbrush	An instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device is typically used with toothpaste. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10818634020861	GS1	Case	8	In Commercial Distribution
Primary	00818634020864	GS1

Customer Contacts

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

Storage Conditions

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