FDA.reportPublic FDA data

ReddyPort

Primary DI
00850001175227
Brand
ReddyPort
Company
SMD Manufacturing LLC
Model
RP-MKITQ4-2
Device description
ReddyPort 24-hour NIV Maintenance Kit follows Q4 protocols (every 4 hours) for standard oral care procedures.
Published
2023-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFWToothbrush, Manual
JOLCatheter And Tip, Suction
KXFApplicator, Absorbent Tipped, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFWToothbrush, ManualDental1
JOLCatheter And Tip, SuctionGeneral Hospital2
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850001175224PackageGS110In Commercial Distribution
00850001175227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000117522410850001175224
00850001175227008500011752278500011752270850001175227

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated manual toothbrushA non-powered instrument designed to be used by a healthcare provider/caregiver to manually brush clean the teeth and gums of a disabled/geriatric patient while simultaneously removing excess oral fluid (saliva, toothpaste). It consists of a proximal handle with a distal bristle head and an integrated suction cannula. It is intended to be used in conjunction with a suction pump (not included). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at Room Temperature

Contacts#

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

Regulatory Flags#

DUNS number
070849038
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
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
10850001175217ReddyPortRP-MKITQ4-12020-11-18
00850001175203Moisturizer RP-MPK-12020-11-18
00850001175005ReddyPortRP-531-L12020-10-28
10850001175002ReddyPortRP-531-L12020-10-28

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