FDA.reportPublic FDA data

APLICARE

Primary DI
10197344007042
Brand
APLICARE
Company
MEDLINE INDUSTRIES, INC.
Model
APL82281S
Catalog number
APL82281S
Device description
LUBRICATING JELLY PACKET, STERILE, 5
Published
2023-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30197344007046PackageGS11000In Commercial Distribution
10197344007042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3019734400704630197344007046
1019734400704210197344007042

GMDN Terms#

Term, Definition table
TermDefinition
General-body orifice lubricantA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry. Keep away from sunlight

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

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
30197344007046APLICAREMEDLINE INDUSTRIES, INC.FHX2023-10-31
00842209101870NAR KitNORTH AMERICAN RESCUE, LLCFHX2018-09-14
00618407002802Aplicare Lubricating JellyAPLICARE, INC.FHX2017-08-17
00618407002819Aplicare 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