FDA.reportPublic FDA data

Q-Care

Primary DI
00618029830760
Brand
Q-Care
Company
SAGE PRODUCTS, LLC
Model
6962
Catalog number
6962
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
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
50618029830765PackageGS110In Commercial Distribution
00618029830760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5061802983076550618029830765
00618029830760006180298307606180298307600618029830760

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 Temperature00

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
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
57613327680749Q-Care698469842025-12-03

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