FDA.reportPublic FDA data

Q-Care Rx

Primary DI
50618029830253
Brand
Q-Care Rx
Company
SAGE PRODUCTS, LLC
Model
9002
Catalog number
9002
Device description
Q-Care Rx Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
Published
2016-09-24
Public version status
Update
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
50618029830253PackageGS120In Commercial Distribution
00618029830258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5061802983025350618029830253
00618029830258006180298302586180298302580618029830258

GMDN Terms#

Term, Definition table
TermDefinition
Dental tooth-cleaning solutionA liquid or gel substance intended to be applied by a dental professional to clean tooth surfaces/cavities, often prior to or following a dental procedure (e.g., restoration, implantation). It typically contains appropriate cleaning agents and may be formulated to prevent plaque accumulation and gingivitis. It is often applied with a syringe, which may be included. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
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
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
57613327680749Q-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
00661392012097LSL HEALTHCARELSL Industries, LLCNSB2025-10-30