FDA.reportPublic FDA data

Q-Care

Primary DI
57613327680749
Brand
Q-Care
Company
SAGE PRODUCTS, LLC
Model
6984
Catalog number
6984
Device description
Sage Q-Care Rx 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
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NSBPatient personal hygiene kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSBPatient Personal Hygiene KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
57613327680749PackageGS120In Commercial Distribution
07613327680744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5761332768074957613327680749
07613327680744076133276807447613327680744

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, Specify00Excursion permitted to 15C to 30C. See USP Controlled Room Temperature
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
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
07613327680720Q-Care682268222025-12-03
07613327680737Q-Care694269422025-12-03
07613327680744Q-Care698469842025-12-03
07613327680751Q-Care682468242025-12-03
57613327680725Q-Care682268222025-12-03
57613327680732Q-Care694269422025-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160536797HalyardMEDICAL ACTION INDUSTRIES INC.NSB2026-09-18
10809160537527HalyardMEDICAL ACTION INDUSTRIES INC.NSB2026-09-18
10809160516577Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2026-03-19
20809160516574Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2026-03-19
10809160513859Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2026-02-25
20809160513856Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2026-02-25
10809160513330MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.NSB2026-02-20
20809160513337MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.NSB2026-02-20
07613327680720Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
57613327680732Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
10889483565315BALLARD™SUNMED, LLCNSB2025-12-01
10889483565339BALLARD™SUNMED, LLCNSB2025-12-01
10889483565346BALLARD™SUNMED, LLCNSB2025-12-01
10889483565353BALLARD™SUNMED, LLCNSB2025-12-01
10889483565360BALLARD™SUNMED, LLCNSB2025-12-01
10889483565384BALLARD™SUNMED, LLCNSB2025-12-01
30889483565319BALLARD™SUNMED, LLCNSB2025-12-01
30889483565333BALLARD™SUNMED, LLCNSB2025-12-01
30889483565340BALLARD™SUNMED, LLCNSB2025-12-01
30889483565357BALLARD™SUNMED, LLCNSB2025-12-01
30889483565364BALLARD™SUNMED, LLCNSB2025-12-01
10889483565377BALLARD™SUNMED, LLCNSB2025-12-01
30889483565388BALLARD™SUNMED, LLCNSB2025-12-01
00661392004580LSL HEALTHCARELSL Industries, LLCNSB2025-10-30
00661392004733LSL HEALTHCARELSL Industries, LLCNSB2025-10-30
00661392012059LSL HEALTHCARELSL Industries, LLCNSB2025-10-30
00661392012066LSL HEALTHCARELSL Industries, LLCNSB2025-10-30