AP50/30 4100

GUDID 00852588007229

High Flow Insufflator

LEXION MEDICAL, LLC

Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator
Primary Device ID00852588007229
NIH Device Record Key636f9d20-4560-451e-a54a-f655ba897819
Commercial Distribution StatusIn Commercial Distribution
Brand NameAP50/30
Version Model Number4100
Catalog Number4100
Company DUNS848693730
Company NameLEXION MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100852588007229 [Primary]
GS100852588007229 [Primary]
GS100852588007229 [Primary]
GS100852588007229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIFInsufflator, Laparoscopic
HIFInsufflator, Laparoscopic
HIFInsufflator, Laparoscopic
HIFInsufflator, Laparoscopic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

Devices Manufactured by LEXION MEDICAL, LLC

00852588007229 - AP50/30 2020-11-10High Flow Insufflator
00852588007229 - AP50/30 2020-11-10 High Flow Insufflator
00852588007069 - VERYCLEAR2020-01-09 SINGLE LUMEN GAS EVACUATION PORT
00852588007083 - INSUFLOW SYNERGY PORT2020-01-09 5mm GAS CONDITIONING PORT
00852588007090 - INSUFLOW SYNERGY XL PORT 2020-01-09 8mm GAS CONDITIONING PORT
00852588007106 - INSUFLOW SYNERGY XL PORT2020-01-09 10mm GAS CONDITIONING PORT
00852588007113 - INSUFLOW SYNERGY XL PORT2020-01-09 12mm GAS CONDITIONING PORT
00852588007120 - INSUFLOW SYNERGY XL PORT2020-01-09 8mm X 130mm GAS CONDITIONING PORT
00852588007137 - iNSUFLOW SYNERGY XL PORT2020-01-09 10mm X 130mm GAS CONDITIONING PORT

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