Bosma Enterprises

Basic Information

• Brand Name: Bosma Enterprises
• Primary DI: 00818634020895
• Version / Model: 10-7100
• Catalog Number: 10-7100
• 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: c0256686-9607-4602-b8d9-6b0a7a24ac9a

Device Description

Shelter in Place and Hygiene Combo Kit; Each Kit Includes 40x80 Disposable Grey Poly Blanket, 13x17 Disposable Pillow, Terry Washcloth (2), 22x44 White Terry Bath Towel, Comb, 4 oz Shampoo/Body Wash, 4 oz Hand and Body Lotion, 2 oz Conditioner, 2 oz Mouthwash, 2 oz Roll-On Antiperspirant Deodorant, Singe Edge Razor, .85 oz Shaving Cream, .85 oz Toothpaste 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
61949	Personal care kit	A collection of devices intended to be used by a patient for personal care needs during a stay in a healthcare institution. It typically contains items such as gown, slippers, cap, hair comb and toothbrush in a storage bag, and may also contain additional personal care products e.g., toothpaste, lotion and deodorant. This is a single-use device.	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
37520	Safety razor, single-use	A hand-held device fitted with an integral razor blade used to remove facial or body hair from a person or patient. It is known as a safety razor because the blade lies protected within the razor head leaving only the cutting edge exposed. This device can be used for skin preparation prior to treatment/surgical intervention or for normal grooming. This is a single-use device.	No	Active
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
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
61257	Antiperspirant	A substance (e.g., gel, solution, cream) intended to be topically applied to the skin (e.g., underarms, hands, feet) to prevent sweating, typically as a treatment for hyperhidrosis. It includes aluminium compounds (e.g., aluminium chloride hexahydrate) and is intended to block the sweat pores through formation of a gel. After application, this device cannot be reused.	No	Active
42345	Dental mouthwash	A substance intended to be used to clean and disinfect the oral cavity (including teeth and gums) for personal hygiene and/or dental clinical procedures. It is available in various forms (e.g., liquid solution, dissolving tablets) which inhibit bacterial growth and sometimes provide specific benefits for teeth (e.g., fluoride, whitening agents). It is intended for use in the home or a clinical setting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10818634020892	GS1	Case	6	In Commercial Distribution
Primary	00818634020895	GS1

Customer Contacts

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

Storage Conditions

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