FDA.reportPublic FDA data

SA-3000P

Primary DI
10191237000011
Brand
SA-3000P
Company
Medicore Co., Ltd.
Model
SA-3000P
Catalog number
SA-3000P
Published
2019-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
K073323000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073323000SA-3000PMedicore Co., Ltd.2007-11-29JOM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10191237000011PackageGS11In Commercial Distribution
00191237000014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019123700001110191237000011
00191237000014001912370000141912370000140191237000014

GMDN Terms#

Term, Definition table
TermDefinition
SphygmographA device that functions as a graphic printer of the waveform of the arterial pulse. This instrument usually includes a lever, the short end of which rests on the radial artery at the wrist, its long end being provided with a stylet which records (usually on a moving paper) the excursions of the pulse. The waveform typically consists of a curve having a sudden rise, followed by a sudden fall, after which there is a gradual descend marked by a number of secondary elevations. This GMDN code may reflect old technology.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82220562650bkyoo@medi-core.com

Regulatory Flags#

DUNS number
688247753
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
00191237000069IRIS-XPIRISIRIS2021-11-01
00191237000014SA-3000PSA-3000PSA-3000P2019-04-10
00191237000038Max PulseMax PulseMax Pulse2019-03-05
40191237000036Max PulseMax PulseMax Pulse2019-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00862467000302PADnetCollaborative Care Diagnostics, LLCJOM2016-09-24
00816787020014DOPPLER MODEL 1050-C W/PPGPARKS MEDICAL ELECTRONICS, INC.JOM2016-09-24