FDA.reportPublic FDA data

ReddyPort

Primary DI
10850001175217
Brand
ReddyPort
Company
SMD Manufacturing LLC
Model
RP-MKITQ4-1
Device description
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.
Published
2020-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXFApplicator, Absorbent Tipped, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850001175217PackageGS110In Commercial Distribution
00850001175210PrimaryGS10
73573-155-14SecondaryNDC/NHRIC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000117521710850001175217
00850001175210008500011752108500011752100850001175210

GMDN Terms#

Term, Definition table
TermDefinition
Oral care kit, single-useA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (801) 899-3036info@reddyport.com

Regulatory Flags#

DUNS number
070849038
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851780008003LineLogic™LL-M-62022-08-01
00851780008102LineLogic™LL-M-72022-08-01
00851780008201LineLogic™LL-M-82022-08-01
00850001175029ReddyPortRP-541-L12024-01-16
00850001175067ReddyPortRP-541-L22024-01-16
00850001175074ReddyPortRP-541-SE2024-01-16
10850001175026ReddyPortRP-541-L12024-01-16
10850001175064ReddyPortRP-541-L22024-01-16
10850001175071ReddyPortRP-541-SE2024-01-16
00850001175227ReddyPortRP-MKITQ4-22023-07-12
10850001175224ReddyPortRP-MKITQ4-22023-07-12
10851780008000LineLogic™LL-M-62022-08-01
10851780008109LineLogic™LL-M-72022-08-01
10851780008208LineLogic™LL-M-82022-08-01
00850001175210ReddyPortRP-MKITQ4-12020-11-18
00850001175203Moisturizer RP-MPK-12020-11-18
00850001175005ReddyPortRP-531-L12020-10-28
10850001175002ReddyPortRP-531-L12020-10-28

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