BESMED SINGLE USE ADULT 1600ML RESUSCITATOR W/O PO

GUDID 04716770224152

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, manual, single-use
Primary Device ID04716770224152
NIH Device Record Keyea8e1d66-ef89-4196-ae51-019af4b344de
Commercial Distribution StatusIn Commercial Distribution
Brand NameBESMED SINGLE USE ADULT 1600ML RESUSCITATOR W/O PO
Version Model NumberRE-22415
Company DUNS658023775
Company NameBESMED HEALTH BUSINESS CORP.
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
GS104716770224152 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-01-25

Devices Manufactured by BESMED HEALTH BUSINESS CORP.

04716770834221 - ICU gas sampling pack2022-08-16 OEM ref: C05096-01-11
04716770834238 - ICU gas sampling pack with flowmeter2022-08-16 OEM ref: C05096-02-11
04716770144306 - Straight Connector 15F/22M, 15M W/PORT & CAP2021-01-15
04716770857398 - FLOW SENSOR, ADULT2021-01-15
04716770790015 - Elbow connetor 18MM ID for nebulizer2020-03-23 Elbow connetor 18MM ID for nebulizer
04716770791043 - MOUTH PIECE (OD:18mm,22mm)2020-03-23 MOUTH PIECE (OD:18mm,22mm)
04716770791081 - MOUTH PIECE(OD:22mm)2020-03-23 MOUTH PIECE(OD:22mm)
04716770791098 - MOUTH PIECE (ID:18mm, OD:19.5mm)2020-03-23 MOUTH PIECE (ID:18mm, OD:19.5mm)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.