FDA.report

EMSRUN

Primary DI
06974567743349
Brand
EMSRUN
Company
Wuxi Emsrun Technology Co., Ltd.
Model
PZBB0005-4
Published
2022-12-06
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

Related Records

Product Codes

CodeName
KYTLight, Examination, Medical, Battery Powered

Product Code Classifications

CodeDeviceSpecialtyClass
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06974567743349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06974567743349069745677433496974567743349

GMDN Terms

TermDefinition
Open surgical site internal lightAn electrically-powered, light-emitting device that includes a light source and is intended to be placed within, or nearly within, a surgical wound/site for illumination during open surgery. It may be fixed to a surgical instrument (e.g., a retractor) and typically operates with either fibreoptic or LED technology to create cold light. This is a single-use device.

Sterilization Methods

Method

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
false

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
04053755202690DELTA 30 UVHeine Optotechnik GmbH & Co. KGKYT2026-03-02
B366LED0204R00PORTALEDEclerisKYT2026-02-11
B366LED0204PORTALEDEclerisKYT2026-01-23
04053755203314DELTA XHeine Optotechnik GmbH & Co. KGKYT2025-12-03
04053755203321DELTA X CPPHeine Optotechnik GmbH & Co. KGKYT2025-12-03
04053755203338DELTA X CPGHeine Optotechnik GmbH & Co. KGKYT2025-12-03
00851289007347FireflyFirefly GlobalKYT2025-07-18
04053755202928DELTAoneHeine Optotechnik GmbH & Co. KGKYT2025-04-30
07465850912003Dr. VampaDr Vampa S.R.L.KYT2025-03-10
07465850912010Dr. VampaDr Vampa S.R.L.KYT2025-03-10
07465850912027Dr. VampaDr Vampa S.R.L.KYT2025-03-10
07465850912034Dr. VampaDr Vampa S.R.L.KYT2025-03-10
07465850912041Dr. VampaDr Vampa S.R.L.KYT2025-03-10
00814005023526RADBL25Quality Aspirators, Inc.KYT2025-02-27
00814005023533RADBLC1Quality Aspirators, Inc.KYT2025-02-27
00814005023540RADFILM5Quality Aspirators, Inc.KYT2025-02-27
00814005023571RADHU2Quality Aspirators, Inc.KYT2025-02-27
00814005023595RADHUM4Quality Aspirators, Inc.KYT2025-02-27
00814005023618RADINST1Quality Aspirators, Inc.KYT2025-02-27
00814005024172RADC25Quality Aspirators, Inc.KYT2025-02-27
00814005024189RADFILM6Quality Aspirators, Inc.KYT2025-02-27
008140050242572 Pin Detachable CableQuality Aspirators, Inc.KYT2025-02-27
00814005024288M-CZQuality Aspirators, Inc.KYT2025-02-27
00814005024295M-ORTTL AssemblyQuality Aspirators, Inc.KYT2025-02-27
00814005024301M-COQuality Aspirators, Inc.KYT2025-02-27
00814005024370M-KEQuality Aspirators, Inc.KYT2025-02-27
00814005024387M-HBQuality Aspirators, Inc.KYT2025-02-27
00814005024394M-ORQuality Aspirators, Inc.KYT2025-02-27
00814005024400M-QFQuality Aspirators, Inc.KYT2025-02-27
00814005024431M-SUQuality Aspirators, Inc.KYT2025-02-27