FDA.reportPublic FDA data

Sage

Primary DI
00618029830241
Brand
Sage
Company
SAGE PRODUCTS, LLC
Model
9001
Catalog number
9001
Device description
Skin Antisepsis and Oral Cleansing
Published
2023-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFWTOOTHBRUSH, MANUAL
KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE
MACDecontamination kit
NSBPatient personal hygiene kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFWToothbrush, ManualDental1
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1
MACDecontamination KitGeneral, Plastic Surgery1
NSBPatient Personal Hygiene KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50618029830246PackageGS120In Commercial Distribution
00618029830241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5061802983024650618029830246
00618029830241006180298302416180298302410618029830241

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature20 Degrees Celsius25 Degrees Celsius
Special Storage Condition, Specify00Store Product Flat. Avoid excessive heat above 40C
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-2220customer-service-spcl@sageproducts.com

Regulatory Flags#

DUNS number
054326178
Device count
1
Premarket exempt
true
Kit
true
Combination product
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
00618029831118Q-Care906290622018-08-10
00618029980274Stryker Fecal Management System700-128700-1282023-03-07
00618029720801Sage Air Tap LC728772872019-10-01
07613327680720Q-Care682268222025-12-03
07613327680737Q-Care694269422025-12-03
07613327680744Q-Care698469842025-12-03
07613327680751Q-Care682468242025-12-03
57613327680725Q-Care682268222025-12-03
57613327680732Q-Care694269422025-12-03
57613327680749Q-Care698469842025-12-03
57613327680756Q-Care682468242025-12-03
07613327632842Sage Multi-Position MATS 2.0323432342025-11-19
07613327632859Sage325032502025-11-19
07613327632866Sage325132512025-11-19
07613327672718Sage Multi-Position MATS 2.0323132312025-11-19
00618029720856Sage AirTAP LC728972892020-04-20
00618029760869Sage Multi-Position MATS323232322021-10-15
07613327632835Sage Multi-Position MATS323332332024-08-12
07613327632873Sage TAP LC728172812024-03-26
07613327632880Sage TAP LC728272822024-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160516577Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2026-03-19
10809160513859Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2026-02-25
10809160513330MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.NSB2026-02-20
07613327680720Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680720Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
M220761002Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXF2025-09-11
10809160492345Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2025-08-18
10304040192471Henry ScheinHENRY SCHEIN, INC.EFW2025-07-08
00072239331057Dr. Brown'sDr. Brown's CompanyEFW2025-05-23
00072239330418Dr. Brown'sDr. Brown's CompanyEFW2025-05-22
10809160450512Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2024-12-30
00072239329122Dr. Brown'sDr. Brown's CompanyEFW2024-04-18
00072239328019Dr. Brown'sDr. Brown's CompanyEFW2024-04-17
00072239328026Dr. Brown'sDr. Brown's CompanyEFW2024-04-17
10809160410288Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2023-10-19
10809160410295Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2023-10-19
10809160409732Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2023-10-06
10809160409589Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2023-09-28
10809160407578Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2023-08-25
10809160407004Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2023-08-15
10810063755673Comfort Tips Soft-Flossing PicksSAFCO DENTAL SUPPLY CO.EFW2023-08-14
10810063755499MR BUBBLES Suction Cup ToothbrushSAFCO DENTAL SUPPLY CO.EFW2023-08-08
10810063755512Crystal Soft ToothbrushSAFCO DENTAL SUPPLY CO.EFW2023-08-08
10810063755451Crystal Soft ToothbrushSAFCO DENTAL SUPPLY CO.EFW2023-08-07