FDA.reportPublic FDA data

Moisturizer

Primary DI
00850001175203
Brand
Moisturizer
Company
SMD Manufacturing LLC
Model
RP-MPK-1
Device description
ReddyPort Moisturizer Pack for use with ReddyPort Elbow. Moisturizer Pack includes: 1x suction swab, 1x mouth moisturizer, 1x applicator swab
Published
2020-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850001175200PackageGS150In Commercial Distribution
00850001175203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000117520010850001175200
00850001175203008500011752038500011752030850001175203

GMDN Terms#

Term, Definition table
TermDefinition
Oral care swabA 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.

Regulatory Flags#

DUNS number
070849038
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing 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
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
10850001175217ReddyPortRP-MKITQ4-12020-11-18
00850001175005ReddyPortRP-531-L12020-10-28
10850001175002ReddyPortRP-531-L12020-10-28

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Primary DI, Brand, Company table
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B382SD9114241000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
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00190776403959MillenniumAvalign Technologies, Inc.JOL2026-07-22
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