4L

GUDID 06970076370069

4L Health Co.,Ltd.

Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set
Primary Device ID06970076370069
NIH Device Record Key49fd808b-7ea0-4f32-88f4-9cfe2b743b5e
Commercial Distribution StatusIn Commercial Distribution
Brand Name4L
Version Model NumberDK10MS
Company DUNS544342742
Company Name4L Health Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970076370069 [Primary]
GS106970076370069 [Primary]
GS106970076370069 [Primary]
GS106970076370069 [Primary]
GS106970076370069 [Primary]
GS106970076370069 [Primary]
GS106970076370069 [Primary]
GS106970076370069 [Primary]
GS106970076370069 [Primary]
GS106970076370069 [Primary]
GS106970076370069 [Primary]
GS106970076370069 [Primary]
GS106970076370069 [Primary]
GS106970076370069 [Primary]
GS106970076370069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OMPNegative Pressure Wound Therapy Powered Suction Pump
OMPNegative Pressure Wound Therapy Powered Suction Pump
OMPNegative Pressure Wound Therapy Powered Suction Pump
OMPNegative Pressure Wound Therapy Powered Suction Pump
OMPNegative Pressure Wound Therapy Powered Suction Pump
OMPNegative Pressure Wound Therapy Powered Suction Pump
OMPNegative Pressure Wound Therapy Powered Suction Pump
OMPNegative Pressure Wound Therapy Powered Suction Pump
OMPNegative Pressure Wound Therapy Powered Suction Pump
OMPNegative Pressure Wound Therapy Powered Suction Pump
OMPNegative Pressure Wound Therapy Powered Suction Pump
OMPNegative Pressure Wound Therapy Powered Suction Pump
OMPNegative Pressure Wound Therapy Powered Suction Pump
OMPNegative Pressure Wound Therapy Powered Suction Pump
OMPNegative Pressure Wound Therapy Powered Suction Pump

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

On-Brand Devices [4L]

06970076370113DK10AS
06970076370076DK10SS
06970076370069DK10MS
06970076370052DK10LS
06970076370014NP32

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