FDA.reportPublic FDA data

Sage

Primary DI
50618029850183
Brand
Sage
Company
SAGE PRODUCTS, LLC
Model
9011
Catalog number
9011
Device description
Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis
Published
2023-10-22
Public version status
New
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
MACDecontamination kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MACDecontamination KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50618029850183PackageGS120In Commercial Distribution
00618029850188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5061802985018350618029850183
00618029850188006180298501886180298501880618029850188

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
054326178
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
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
00618029791399SageSAGE PRODUCTS, LLCMAC2023-10-22
00618029830241SageSAGE PRODUCTS, LLCMAC2023-10-22
00618029850188SageSAGE PRODUCTS, LLCMAC2023-10-22
05391540450079ABD DeviceAQUILA BIOSCIENCE LIMITEDMAC2022-12-01
20653160139161CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-02
00653160233421CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-02
10653160233428CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-02
10653160139164CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-02
10653160240754CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
10653160287919CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
10653160294207CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
10653160313120CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160019285CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160019964CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160021868CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160024975CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160027075CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160053203CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160065848CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160119411CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160201024CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160209891CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160019280CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160019969CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160021863CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160024970CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160027070CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160053208CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160065843CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
10653160119418CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01