FDA.reportPublic FDA data

Q-Care

Primary DI
07613327680720
Brand
Q-Care
Company
SAGE PRODUCTS, LLC
Model
6822
Catalog number
6822
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
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOLCATHETER AND TIP, SUCTION
KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE
NSBPatient personal hygiene kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1
NSBPatient Personal Hygiene KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
57613327680725PackageGS110In Commercial Distribution
07613327680720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5761332768072557613327680725
07613327680720076133276807207613327680720

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
00618029980052Sage Fecal Management System700-118700-1182021-10-15
00618029980274Stryker Fecal Management System700-128700-1282023-03-07
00618029830128Q-Care Rx6904-PS6904-PS2023-09-07
00618029810328Toothette Oral Care400040002016-09-24
00618029830081Q-Care690469042016-09-24
00618029830166Q-Care691269122016-09-24
00618029830173Q-Care691469142016-09-24
00618029830753Q-Care696469642016-09-24
00618029830760Q-Care696269622016-09-24
00618029830975Q-Care697469742019-07-10
00618029831125Q-Care699269922018-12-10
00618029831149Q-Care Rx698269822018-12-10
00618029831118Q-Care906290622018-08-10
00618029720801Sage Air Tap LC728772872019-10-01
07613327680737Q-Care694269422025-12-03
07613327680744Q-Care698469842025-12-03
07613327680751Q-Care682468242025-12-03
57613327680725Q-Care682268222025-12-03
57613327680732Q-Care694269422025-12-03
57613327680749Q-Care698469842025-12-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00827002606647OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606654OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606661OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
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00827002606685OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
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00827002606715OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606722OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
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00827002606746OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
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00827002606760OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606777OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606784OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606791OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606807OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606814OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606821OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002613553CookCOOK INCORPORATEDJOL2026-10-22
10809160540626HalyardMEDICAL ACTION INDUSTRIES INC.KXF2026-10-14
10609576010191Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-10-09
00190776436384MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436391MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436407MillenniumAvalign Technologies, Inc.JOL2026-10-08