DEVICE: ReddyPort (00850001175210)

Device Identifier (DI) Information

ReddyPort
RP-MKITQ4-1
In Commercial Distribution

SMD Manufacturing LLC
00850001175210
GS1

1
070849038 *Terms of Use
24 hour maintenance kit for oral care with ReddyPort Elbow. 24 hour maintenance kit includes: 1x prep pack (yankauer), 2x suction silicone toothbrush packs with anti-plaque solution (cetylpyridinium chloride 0.05%), applicator swabs and mouth moisturizer, 4x suction swab packs with suction swab, applicator swab, antiseptic oral rinse (hydrogen peroxide 1.5%) and mouth moisturizer.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
Yes
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?
45172 Oral care kit, single-use
A collection of various devices and supplies used for a patient's oral hygiene. It typically includes an antiseptic applicator swab, a pre-treated toothbrush, mouth swabs, and a mouthwash/oral moisturizer. Its use will improve the physical condition of the oral cavity and may help reduce the incidence of patient infection. It is typically applied by nursing staff in hospitals and institutions, or attendants in home care settings. 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
34524 Dental tooth-cleaning solution
A liquid or gel substance intended to be applied by a dental professional to clean tooth surfaces/cavities, often prior to or following a dental procedure (e.g., restoration, implantation). It typically contains appropriate cleaning agents and may be formulated to prevent plaque accumulation and gingivitis. It is often applied with a syringe, which may be included. After application, this device cannot be reused.
Active false
48037 Oral care swab
A device designed as a piece of non-treated, absorbent material on a wooden, paper, or plastic stick and intended to moisten and clean a patient's oral cavity to maintain normal mouth patency and hygiene. It is commonly used on intensive care and long-term care patients to administer moisture, mouthwash, or medications to improve the physical condition of the oral cavity and possibly help reduce the incidence of patient infection. It is typically applied to the patient by nursing staff in hospitals and institutions, or attendants in homecare settings. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KXF Applicator, Absorbent Tipped, Non-Sterile
JOL Catheter And Tip, Suction
EFW Toothbrush, Manual
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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
No storage/handling found
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Clinically Relevant Size

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

c77594b1-23a6-4f15-8d4d-99b759c9f3e2
June 09, 2022
2
November 18, 2020
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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
10850001175217 10 00850001175210 In Commercial Distribution Case
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
NDC/NHRIC 73573-155-14
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1 (801) 899-3036
info@reddyport.com
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