FDA.reportPublic FDA data

PADnet

Primary DI
00862467000302
Brand
PADnet
Company
Collaborative Care Diagnostics, LLC
Model
2.0
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOMPlethysmograph, Photoelectric, Pneumatic Or HydraulicCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122281000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122281000PADNET 2.0Biomedix, Inc.2012-08-29JOM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862467000302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862467000302008624670003028624670003020862467000302

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
029870178
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862467000333PADnet Xpress1.02026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011800613CardioTagCARDIOSENSE, INC.JOM2026-10-14
00862467000333PADnet XpressCollaborative Care Diagnostics, LLCJOM2026-02-04
08690020003017VitalScan ANSMedeia, Inc.JOM2025-02-05
08690020003031VitalScan HRVMedeia, Inc.JOM2025-02-05
B322G0011ANS1 SoftwareLD TECHNOLOGY, LLCJOM2024-03-05
B322H0011LD-EKGLD TECHNOLOGY, LLCJOM2024-03-05
05051968035370DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDJOM2022-10-10
03830059851523MESI mTABLET TBIMESI d.o.o.JOM2022-04-25
03830059850366MESI ABPI MDMESI d.o.o.JOM2021-07-09
03830059851141MESI mTABLET ABIMESI d.o.o.JOM2021-07-09
00884838093188Avalon Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbHJOM2021-03-08
00884838093195Avalon Ultrasound TransducerPhilips Medizin Systeme Böblingen GmbHJOM2021-03-08
00884838093201Avalon ECG/IUP TransducerPhilips Medizin Systeme Böblingen GmbHJOM2021-03-08
00884838093218Avalon Toco MP TransducerPhilips Medizin Systeme Böblingen GmbHJOM2021-03-08
00884838093225Avalon Toco+ TransducerPhilips Medizin Systeme Böblingen GmbHJOM2021-03-08
00191237000014SA-3000PMedicore Co., Ltd.JOM2019-04-10
10191237000011SA-3000PMedicore Co., Ltd.JOM2019-04-10
00191237000038Max PulseMedicore Co., Ltd.JOM2019-03-05
40191237000036Max PulseMedicore Co., Ltd.JOM2019-03-05
B322C0011TBL-ABILD TECHNOLOGY, LLCJOM2019-01-16
04051526846302MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
04051526846463MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
04051526849631MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
04051526903616MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
00636257188439MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
00636257189085MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
00817065022454HokansonD.E.HOKANSON, INC.JOM2017-12-12
05051968030429DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDJOM2016-11-07
05051968030436DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDJOM2016-11-07
00860446000312APG Air-PlethysmographACI MEDICAL LLCJOM2016-09-24