DEVICE: Bosma Enterprises (00818634020901)
Device Identifier (DI) Information
Bosma Enterprises
10-7225
In Commercial Distribution
10-7225
Bosma Enterprises
10-7225
In Commercial Distribution
10-7225
Bosma Enterprises
Hygiene Kit; Each Kit Includes Comb, 2 oz Mouthwash, 4 oz Shampoo/Body Wash, .85 oz Shaving Cream, .85 oz Toothpaste and Toothbrush.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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Yes | |
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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.
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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.
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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.
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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).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NXZ | Dental Hygiene Kit |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Avoid excessive heat. Keep dry. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
aea010f2-cf7b-466a-9dc3-b071912517b3
July 12, 2021
1
July 02, 2021
July 12, 2021
1
July 02, 2021
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-362-5463
kimm@bosma.org
kimm@bosma.org