FDA.reportPublic FDA data

Good Vibrations

Primary DI
H816GVUSU240
Brand
Good Vibrations
Company
MicroCare, LLC
Model
GVUSU24
Catalog number
GVUSU24
Device description
Good Vibrations Unit Dose
Published
2024-08-21
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JCBDetergent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCBDetergentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H816GVUSU24PrimaryHIBCC0
H816GVUSU240Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical device cleaning agentA substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118518186
Device count
6
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H816MPM10161ProView PlusPM1016PM1016-12022-10-26
H816MPM13181ProView PlusPM1318PM1318-12022-10-26
H816MPM24401ProView PlusPM2440PM2440-12022-10-26
H816MPM27901ProView PlusPM2790PM2790-12022-10-26
H816MPM35541ProView PlusPM3554PM3554-12022-10-26
H816MPM35901ProView PlusPM3590PM3590-12022-10-26
H816MPM54101ProView PlusPM5410PM5410-12022-10-26
H816GEL121Spec Clean Pre Treatment GelGEL12GEL122025-10-23
H816OP1281OptizymeOP128OP1282025-10-23
H816PSC050Spec Clean Ready to Use DisinfectantPSC050PSC0502025-10-23
H816PSC128Spec Clean Ready to Use DisinfectantPSC128PSC1282025-10-23
H816PSC240Spec Clean Ready to Use DisinfectantPSC240PSC2402025-10-23
H816PSC6032Spec Clean Concentrated DisinfectantPSC6032PSC60322025-10-23
H816EZ128Spec Clean Single Enzymatic DetergentEZ128EZ1282025-10-22
H816EZTAB641Spec Clean Enzymatic TabletsEZTAB64EZTAB642025-10-22
H816PCNF128Spec Clean Instrument Detergent AlkalinePCNF128PCNF1282025-10-22
H816PLC128Spec Clean Concentrated Instrument LubricantPLC128PLC1282025-10-22
H816PLR32Spec Clean Instrument LubricantPLR32PLR322025-10-22
H816PREZ128Spec Clean Dual Enzymatic DetergentPREZ128PREZ1282025-10-22
H816PREZ275Spec Clean Dual Enzymatic DetergentPREZ275PREZ2752025-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740750622Detergent for Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JCB2026-04-16
06935740750639Detergent for Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JCB2026-04-16
06935740750646Detergent for Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JCB2026-04-16
08436583731888Grifols Wash Solution ADIAGNOSTIC GRIFOLS SAJCB2026-03-13
08436583731895Grifols Wash Solution BDIAGNOSTIC GRIFOLS SAJCB2026-03-13
06936415904678MR Detergent SolutionShenzhen Mindray Bio-Medical Electronics Co., Ltd.JCB2026-01-23
06936415904685MR Buffer SolutionShenzhen Mindray Bio-Medical Electronics Co., Ltd.JCB2026-01-23
06936415994457PROBE CLEANSERShenzhen Mindray Bio-Medical Electronics Co., Ltd.JCB2026-01-22
06944904030210PROBE CLEANSERShenzhen Mindray Bio-Medical Electronics Co., Ltd.JCB2026-01-22
159998600941705x TBS Wash BufferDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-12-11
059998600941735x TBS Wash BufferDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-12-11
15999883586751Atellica DT Solution 1 (S1)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
15999883586867Atellica DT Solution 4 (S4)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
45999883586752Atellica DT Solution 2 (S2)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
25999883586758Atellica DT Solution 1 (S1)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
15999883586850Atellica DT Solution 3 (S3)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
25999883586864Atellica DT Solution 4 (S4)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
55999883586759Atellica DT Solution 2 (S2)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
00739470000011Micro-Scientific Enzyclean IIMICRO-SCIENTIFIC, LLCJCB2025-04-29
00739470000028Micro-Scientific EnzycleanMICRO-SCIENTIFIC, LLCJCB2025-04-29
00739470000066Micro-Scientific MicroKleen HSMICRO-SCIENTIFIC, LLCJCB2025-04-29
00739470000158Micro-Scientific Enzyclean II LSMICRO-SCIENTIFIC, LLCJCB2025-04-29
00739470000172Micro-Scientific MicroKleen LSMICRO-SCIENTIFIC, LLCJCB2025-04-29
00739470400163Micro-Scientific Enzyclean IVMICRO-SCIENTIFIC, LLCJCB2025-04-29
10739470000018Micro-Scientific Enzyclean IIMICRO-SCIENTIFIC, LLCJCB2025-04-29
10739470000025Micro-Scientific EnzycleanMICRO-SCIENTIFIC, LLCJCB2025-04-29
10739470000063Micro-Scientific MicroKleen HSMICRO-SCIENTIFIC, LLCJCB2025-04-29
10739470000155Micro-Scientific Enzyclean II LSMICRO-SCIENTIFIC, LLCJCB2025-04-29
10739470000179Micro-Scientific MicroKleen LSMICRO-SCIENTIFIC, LLCJCB2025-04-29
50739470400168Micro-Scientific Enzyclean IVMICRO-SCIENTIFIC, LLCJCB2025-04-29