FDA.reportPublic FDA data

Q-Care

Primary DI
57613327680756
Brand
Q-Care
Company
SAGE PRODUCTS, LLC
Model
6824
Catalog number
6824
Device description
Sage Q-Care Oral Cleansing and Suctioning System
Published
2025-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
57613327680756PackageGS120In Commercial Distribution
07613327680751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5761332768075657613327680756
07613327680751076133276807517613327680751

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.

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
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
57613327632830Sage Multi-Position MATS323332332024-08-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10609576331432Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576331449Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576331586Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576340007Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576360203Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576360210Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576360241Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
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30609576800161Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800185Puritan® CalgiSwab®Puritan Medical ProductsKXF2026-07-20
30609576800208Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800406Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800543Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800604Puritan®Puritan Medical ProductsKXF2026-07-20