Disposable Resuscitator

GUDID 04719872109631

Disposable Resuscitator

ENTER MEDICAL CORPORATION

Pulmonary resuscitator, manual, reusable
Primary Device ID04719872109631
NIH Device Record Key7f5e3c77-111f-4114-bb2b-a32e6f753a8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Resuscitator
Version Model NumberENT-1001
Company DUNS658833116
Company NameENTER MEDICAL CORPORATION
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719872109631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTMVentilator, Emergency, Manual (Resuscitator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-27
Device Publish Date2023-10-19

Devices Manufactured by ENTER MEDICAL CORPORATION

04719872100607 - RESERVOIR2023-10-27 RESERVOIR
04719872101208 - Seal Rite Mask2023-10-27 Seal Rite Mask
04719872102021 - Catheter Mount2023-10-27 Catheter Mount
04719872103028 - Bubble Humidifier2023-10-27 Bubble Humidifier
04719872104414 - Nasal Cannula2023-10-27 Nasal Cannula
04719872104568 - reusable resuscitator2023-10-27 reusable resuscitator
04719872109631 - Disposable Resuscitator2023-10-27Disposable Resuscitator
04719872109631 - Disposable Resuscitator2023-10-27 Disposable Resuscitator
04719872109853 - Anaesthetic Face Mask2023-10-27 Anaesthetic Face Mask

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