FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380100328
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
LJ33121
Catalog number
LJ33121
Device description
Cardinal Health Lubricating Jelly
Published
2017-04-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KMJLubricant, patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMJLubricant, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885380100328PackageGS112In Commercial Distribution
50885380100329PackageGS18In Commercial Distribution
10885380100321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538010032820885380100328
5088538010032950885380100329
1088538010032110885380100321

GMDN Terms#

Term, Definition table
TermDefinition
General-body orifice lubricant, non-sterileA non-sterile substance intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device; 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
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16936603230999Medical LubricantYangzhou Fartley Medical Instrument Technology Co., LtdKMJ2025-06-23
40080196074199MEDLINEMEDLINE INDUSTRIES, INC.KMJ2025-04-25
17290100666156Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2025-04-02
00858276007557Sterile Bacteriostatic Lubricating GelMicro-tech UsaKMJ2025-03-05
10850025860489Endoscopy Kit - Basic + GownsMicro-tech UsaKMJ2025-03-04
00850025860079Endoscopy Kit - Basic+Micro-tech UsaKMJ2025-03-03
00850025860222Endoscopy Kit - Compliance+Micro-tech UsaKMJ2025-03-03
00850025860284Endoscopy Kit - ComplianceMicro-tech UsaKMJ2025-03-03
00858276007441Endoscopy Kit - BasicMicro-tech UsaKMJ2025-03-03
00858276007472Endoscopy Kit - UpperMicro-tech UsaKMJ2025-03-03
00858276007502Endoscopy Kit - Set UpMicro-tech UsaKMJ2025-03-03
E23905651Otoferm® CremeDreve Otoplastik GmbHKMJ2024-06-25
34026704921691ARROWTELEFLEX INCORPORATEDKMJ2024-04-08
30810132041762HCSConcordance Healthcare Solutions LLCKMJ2023-10-10
17290100663308Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2023-09-19
07290100663288Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2023-09-19
07290100663301Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2023-09-19
00304040165157Henry ScheinHENRY SCHEIN, INC.KMJ2023-07-31
00304040165164Henry ScheinHENRY SCHEIN, INC.KMJ2023-07-31
20326053104835Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.KMJ2023-06-29
20326053104842Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.KMJ2023-06-29
20326053104859Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.KMJ2023-06-29
05030267124381OPTILUBE BOX OF 150 SACHETSIntersurgical IncorporatedKMJ2023-06-15
30810132040642HCSConcordance Healthcare Solutions LLCKMJ2023-04-07
00850047788115Oto Ease 12pk Display BoxWestone Laboratories, Inc.KMJ2023-03-02
00850047788122Oto-Ease 1/2oz bottle 1 packWestone Laboratories, Inc.KMJ2023-03-02
00850047788139Oto-Ease 1/2-oz bottles 5/pkWestone Laboratories, Inc.KMJ2023-03-02
00850047788146Oto-Ease Single Dose - 100/pkWestone Laboratories, Inc.KMJ2023-03-02
40080196291572MedlineMEDLINE INDUSTRIES, INC.KMJ2023-02-04
20326053118535Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.KMJ2023-01-13