FDA.report

HR Lubricating Jelly 2X

Primary DI
30851809002105
Brand
HR Lubricating Jelly 2X
Company
HR PHARMACEUTICALS INC.
Model
210
Catalog number
210
Device description
Sterile Lubricating Jelly, Tube
Published
2018-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KMJLubricant, patient

Product Code Classifications

CodeDeviceSpecialtyClass
KMJLubricant, PatientGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30851809002105PackageGS1192In Commercial Distribution
00851809002104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3085180900210530851809002105
00851809002104008518090021048518090021040851809002104

GMDN Terms

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

TypeValueUnit
Weight56.5Gram

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method
Liquid Chemical

Contacts

PhoneEmail
+1(717)252-1110chris.wiesman@hrpharma.com

Regulatory Flags

DUNS number
828918164
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
50850058254673EZ-Advancer®AKC142026-03-06
50850058254680TruAdvance™TAC142026-03-06
10850067913006TruLockTLFS302026-03-06
10850067913013TruLockTLFS562026-03-06
50850058254451EZ-Protect™10108H2026-02-05
00850058254463EZ-Protect™10110H2026-02-05
50850058254475EZ-Protect™10112H2026-02-05
50850058254482EZ-Protect™10114H2026-02-05
50850058254499EZ-Protect™10116H2026-02-05
50850058254505EZ-Protect™10118H2026-02-05
50850058254512EZ-Protect™12108H2026-02-05
50850058254529EZ-Protect™12110H2026-02-05
50850058254536EZ-Protect™12112H2026-02-05
50850058254543EZ-Protect™12114H2026-02-05
50850058254550EZ-Protect™12116H2026-02-05
50850058254567EZ-Protect™12118H2026-02-05
50850045818468TruAdvance®FTDS14UM2025-12-22
50850045818475TruAdvance®FTDS16UM2025-12-22
50850045818482TruAdvance®FTDS18UM 2025-12-22
50850058254888TruAdvanceFTTS14UM2025-09-11

Other Devices Sharing Product Codes

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