FDA.reportPublic FDA data

EMSRUN

Primary DI
06974567741260
Brand
EMSRUN
Company
Wuxi Emsrun Technology Co., Ltd.
Model
PZDM0001
Published
2022-12-02
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

Product Codes#

Code, Name table
CodeName
LRJDisinfectant, Medical Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRJDisinfectant, Medical DevicesGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974567741260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974567741260069745677412606974567741260

GMDN Terms#

Term, Definition table
TermDefinition
Radiation prep-pad warmerA mains electricity (AC-powered) device designed to heat factory-sealed prep pads (skin cleansing pads typically containing alcohol or povidone iodine), with a pre-set maximum temperature (e.g., 55?C) for the purpose of warming the pads prior to use on a paediatric patient, notably to reduce the number of venous access attempts (needle sticks). The device is typically of tabletop design and includes a heat exchanger that uses electromagnetic radiation (e.g., radio-frequency, microwaves) to transmit heat to the packaged pads that have been placed in separate compartments within the device; it also includes temperature controls and/or alarms.

Sterilization Methods#

Method table
Method
High Intensity Light or Pulse Light

Regulatory Flags#

DUNS number
542972552
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974567744704EMSRUNPZJD0020-22022-12-13
16974567747511RHINO RESCUECPDJ00052024-11-12
16974567747528RHINO RESCUECPHW00222024-10-24
16974567747771RHINO RESCUECP00252024-10-14
16974567747795RHINO RESCUECP00262024-10-14
16974567747535RHINO RESCUEPZZX00722024-10-12
06974567746630RHINO RESCUECPHW00022024-01-08
16974567748297Rhino RescuePZXF00012022-12-12
16974567749584Rhino RescueTJTK04022022-12-08
06974567749594Rhino RescueTJTK04072022-12-08
06974567749600Rhino RescueTJTK04062022-12-08
06974567749617Rhino RescueTJTK04052022-12-08
06974567749624Rhino RescueTJTK04042022-12-08
16974567749645Rhino RescueTJTK04032022-12-08
16974567749652Rhino RescueTJTK04012022-12-08
16974567749669Rhino RescueTJIK00062022-12-08
16974567749676Rhino RescueTJIK00052022-12-08
16974567749683Rhino RescueTJIK00042022-12-08
16974567749690Rhino RescueTJIK00032022-12-08
16974567749706Rhino RescueTJIK00022022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344169082MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-12-09
00850080488072flysoundShenzhen Flysounds Medical Technology Co.,Ltd.LRJ2025-11-14
08859335502220POSE HEALTH CARE LIMITED POSE HEALTH CARE LIMITEDLRJ2025-09-05
10615375013455CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
10615375013479CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
00815027010303DALTON WET WIPEDALTON MEDICAL CORPORATIONLRJ2025-05-15
00025469093455Ecolab Bleach Disinfectant WipeEcolab Inc.LRJ2025-05-09
00850065253244LIVE TULA Alcohol Pads 1.0 (100pcs/box)TULA HEALTH, INC.LRJ2025-03-18
06976301910710YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910727YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910734YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910741YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910758YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910765YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910772YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910789YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910796YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
20197344017680MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-02-28
20197344017697MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-02-28
10855424008678Just for HerMKJ Brands Limited Liability CompanyLRJ2024-11-25
D6620708506020Patterson®PATTERSON DENTAL SUPPLY, INC.LRJ2024-11-11
D66207085061009Patterson®PATTERSON DENTAL SUPPLY, INC.LRJ2024-11-11
D6620708771910Patterson®PATTERSON DENTAL SUPPLY, INC.LRJ2024-11-11
D6620708772090Patterson®PATTERSON DENTAL SUPPLY, INC.LRJ2024-11-11
20193489189541MEDLINEMEDLINE INDUSTRIES, INC.LRJ2024-11-08
10192253052862DevonCardinal Health 200, LLCLRJ2024-10-25
00860012058204Ritewipe Dental Handpiece Cleaning WipesRITEWIPE, LLCLRJ2024-09-09
D956DSTCLEAN0DS Impression Tray Cleaner PowderD.S.I DENTAL SOLUTIONS LTDLRJ2024-06-26
20888277652511MedlineMEDLINE INDUSTRIES, INC.LRJ2024-06-06
20888277652528MedlineMEDLINE INDUSTRIES, INC.LRJ2024-06-06