FDA.reportPublic FDA data

Aplicare Lubricating Jelly

Primary DI
00618407002819
Brand
Aplicare Lubricating Jelly
Company
APLICARE, INC.
Model
82-281
Catalog number
82-281
Device description
Lubricating Jelly
Published
2017-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHXJELLY, LUBRICATING, FOR TRANSURETHRAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHXJelly, Lubricating, For Transurethral Surgical InstrumentGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K912132000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K912132000OPERAND LUBRICATING JELLYGeneral Medical Co.1991-08-07FHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10618407002816PackageGS1150In Commercial Distribution
30618407002810PackageGS14In Commercial Distribution
40618407002817PackageGS11000In Commercial Distribution
00618407002819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061840700281610618407002816
3061840700281030618407002810
4061840700281740618407002817
00618407002819006184070028196184070028190618407002819

GMDN Terms#

Term, Definition table
TermDefinition
General-body orifice lubricant, sterileA sterile substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Weight5Gram

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)760-3236aplicarecustomerservice@clorox.com

Regulatory Flags#

DUNS number
058377631
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00618407002802Aplicare Lubricating Jelly82-28082-2802017-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344007035APLICAREMEDLINE INDUSTRIES, INC.FHX2024-01-23
30197344007039APLICAREMEDLINE INDUSTRIES, INC.FHX2024-01-23
10197344007042APLICAREMEDLINE INDUSTRIES, INC.FHX2023-10-31
30197344007046APLICAREMEDLINE INDUSTRIES, INC.FHX2023-10-31
00842209101870NAR KitNORTH AMERICAN RESCUE, LLCFHX2018-09-14
00618407002802Aplicare Lubricating JellyAPLICARE, INC.FHX2017-08-17
10884389706343Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FHX2016-09-29
00749756026512DeRoyalDEROYAL INDUSTRIES, INC.FHX2016-09-12
00749756033756DeRoyalDEROYAL INDUSTRIES, INC.FHX2016-09-12
00749756770378DeRoyalDEROYAL INDUSTRIES, INC.FHX2016-09-12
50749756026517DeRoyalDEROYAL INDUSTRIES, INC.FHX2016-09-12
50749756033751DeRoyalDEROYAL INDUSTRIES, INC.FHX2016-09-12
50749756770373DeRoyalDEROYAL INDUSTRIES, INC.FHX2016-09-12