DEVICE: Bosma Enterprises (00818634020901)

Device Identifier (DI) Information

Bosma Enterprises
10-7225
In Commercial Distribution
10-7225
Bosma Enterprises
00818634020901
GS1

1
878070325 *Terms of Use
Hygiene Kit; Each Kit Includes Comb, 2 oz Mouthwash, 4 oz Shampoo/Body Wash, .85 oz Shaving Cream, .85 oz Toothpaste and Toothbrush.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
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.
Active false
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.
Active false
41551 Liquid skin soap
A liquid cleansing agent designed for washing the skin, typically the hands but also the rest of the body. It contains fatty acid salts and is typically delivered in a disposable pack which is mounted into a dispenser, where the user can, e.g., dispense the liquid soap into the palm of his/her hand by operating a pumping mechanism. It is normally available [non-prescription] over-the-counter (OTC).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NXZ Dental Hygiene Kit
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Avoid excessive heat. Keep dry.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

aea010f2-cf7b-466a-9dc3-b071912517b3
July 12, 2021
1
July 02, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10818634020908 25 00818634020901 In Commercial Distribution Case
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
800-362-5463
kimm@bosma.org
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