FDA.reportPublic FDA data

OP - First aid series

Primary DI
06974686050021
Brand
OP - First aid series
Company
Yiwu Ori-Power Medtech Co.,Ltd.
Model
OP401
Published
2022-02-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OVRKit, First Aid, Talking

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVRKit, First Aid, TalkingGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974686050021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974686050021069746860500216974686050021

GMDN Terms#

Term, Definition table
TermDefinition
Germicidal spongeA device impregnated with an antimicrobial agent and intended to be applied to a surgical incision, other skin wound, or an internal structure to control bleeding, absorb fluid, and to protect against contamination. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
560451976
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06942509220357OP - First aid seriesOP300.634587.0038.007.02026-03-13
06942509220364OP - First aid seriesOP300.634588.0038.007.02026-03-13
06942509220371OP - First aid seriesOP300.634589.0038.007.02026-03-13
06942509220142OP - First aid series32704.634110.0566.000.02025-10-28
06942509220258OP - First aid series32101.634688.0661.007.0 2025-10-28
06942509220265OP - First aid seriesOP300.634070.0038.000.02025-10-28
06942509220289OP - First aid seriesOP300.634295.0038.002.02025-10-28
06942509220296OP - First aid seriesOP300.634322.0038.007.02025-10-28
06942509220302OP - First aid seriesOP300.634343.0038.007.02025-10-28
06942509220319OP - First aid seriesOP300.634487.0038.007.02025-10-28
06942509220333OP - First aid seriesOP300.634686.0038.070.02025-10-28
06942509220029OP - First aid seriesOP300.632631.0038.013.02025-08-30
06942509220036OP - First aid seriesOP30051442025-08-30
06942509220043OP - First aid seriesOP300.633104.0038.007.02025-08-30
06942509220081OP - First aid seriesOP300.633297.0038.108.02025-08-30
06942509220098OP - First aid seriesOP300.633291.0038.107.02025-08-30
06942509220104OP - First aid seriesOP300.633300.0038.109.02025-08-30
06942509220111OP - First aid seriesOP300.633137.0038.041.02025-08-30
06942509220128OP - First aid seriesOP300.633141.0038.010.02025-08-30
06942509240126OP - First aid series32702.633996.0000.000.02025-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810132043956HCSConcordance Healthcare Solutions LLCOVR2025-03-04
06975033060069WAPShenzhen WAP-health Technology Co.LtdOVR2024-07-12
00847946050504MOBILIZE RESCUE SYSTEMS, COMPACZoll Medical CorporationOVR2022-08-25
00847946050511MOBILIZEZoll Medical CorporationOVR2022-08-25
00847946050528MOBILIZEZoll Medical CorporationOVR2022-08-25
00847946050535MOBILIZEZoll Medical CorporationOVR2022-08-25
00847946050542MOBILIZEZoll Medical CorporationOVR2022-08-25
B283E1SBDPDBP0PRO1TEK Trauma First Aid Advanced Kit- 1+ Patient Pro1tekOVR2022-05-03
B283EIF1BBP0PRO1TEK Trauma First Aid Advanced IFAK Kit Pro1tekOVR2022-05-03
B283PTOXFIFAK010PRO1TEK 2+Patient Specialty IFAK Kit Pro1tekOVR2022-04-27
B283E1BB0PRO1TEK 2+ Patient IFAK Kit Pro1tekOVR2022-03-23
B283E6HCXOC0EMPACT 6+ Patient Trauma Kit with Batons-OTCPro1tekOVR2022-03-23
B283E6HCXPD0EMPACT 6+ Patient Hard Case Trauma Kit- Bat Flashlight RXPro1tekOVR2022-03-23
B28300EMPACT 6+ Patient Hard Case Kit with Wall Cabinet Pro1tekOVR2021-05-27
B283E6HCXOB0EMPACT 6+ Patient Hard Case Kit with Wall Cabinet OTCPro1tekOVR2021-05-27
B283P1FDPD0PRO1TEK IFAK EMT BAG Pro1tekOVR2021-05-27
B283P1FDPD20PRO1TEK IFAK EMT CCR Leg RIG BAG Pro1tekOVR2021-05-27
B283P1FDPD30PRO1TEK IFAK EMT Leg RIG BAG Pro1tekOVR2021-05-27
B283E6HCXPAC0EMPACT 6+ Patient Hard Case Refurbish Kit Pro1tekOVR2020-11-02
B283CTKOST10PRO1TEK Trauma First Aid Bleeding Control Kit - Vehicle Kit Pro1tekOVR2019-03-21
B283E1TCPB0PRO1TEK Trauma First Aid Advanced Bleeding Kit- 1+ Patient with C.A.T. Pro1tekOVR2018-09-25
B283E1TCPD0PRO1TEK Trauma First Aid Advanced Bleeding Control Kit- 1+ Patient with SWAT T Pro1tekOVR2018-09-25
B283E2IFBPD0PRO1TEK Trauma First Aid Advanced Bleeding Control Kit- 2+ Patient IFAK w/BC Pro1tekOVR2018-09-25
B283E6HCXPE0EMPACT Active Shooter Tool Kit- Advanced Bleeding Control- 6+ Patient HCPro1tekOVR2018-09-25
B283E6HCXPG0EMPACT Active Shooter Tool Kit- Advanced Bleeding Control w/SWAT TPro1tekOVR2018-09-25
B283ECRB0PRO1TEK Trauma First Aid Advanced Bleeding Control Kit- 2+ Patient Vehicle Kit Pro1tekOVR2018-09-25
B283EIDPD0PRO1TEK Trauma First Aid Advanced Bleeding Control Kit- 2+ Patient IFAK w/ NasoPro1tekOVR2018-09-25
B283ELXB0EMPACT Active Shooter Tool Kit- Advanced Bleeding Control Kit- 10+ Patient Pro1tekOVR2018-09-25
B283ESRB0EMPACT Active Shooter Tool Kit Advanced Bleeding Control- 2-4+ Patient Kit Pro1tekOVR2018-09-25
B283E2IFBPC0PRO1TEK Trauma First Aid Advanced Bleeding Control- 2+ Patient IFAK Pro1tekOVR2018-09-24