FEATHER-FLEX OL-649503-00/NSP0203

GUDID 20629160000305

3 LITRE DISPOSABLE LATEX FREE BREATHING BAG

BOMImed Inc

Breathing circuit bag, single-use Breathing circuit bag, single-use Breathing circuit bag, single-use Breathing circuit bag, single-use Breathing circuit bag, single-use Breathing circuit bag, single-use Breathing circuit bag, single-use Breathing circuit bag, single-use Breathing circuit bag, single-use Breathing circuit bag, single-use Breathing circuit bag, single-use
Primary Device ID20629160000305
NIH Device Record Keybf6963c1-4181-4df6-ac2f-b5f4a3e2b7f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameFEATHER-FLEX
Version Model Number3L
Catalog NumberOL-649503-00/NSP0203
Company DUNS248200149
Company NameBOMImed Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone204-633-2664
Emailregulatory@bomimed.com
Phone204-633-2664
Emailregulatory@bomimed.com
Phone204-633-2664
Emailregulatory@bomimed.com
Phone204-633-2664
Emailregulatory@bomimed.com
Phone204-633-2664
Emailregulatory@bomimed.com
Phone204-633-2664
Emailregulatory@bomimed.com
Phone204-633-2664
Emailregulatory@bomimed.com
Phone204-633-2664
Emailregulatory@bomimed.com
Phone204-633-2664
Emailregulatory@bomimed.com
Phone204-633-2664
Emailregulatory@bomimed.com
Phone204-633-2664
Emailregulatory@bomimed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110629160000339 [Primary]
GS120629160000305 [Package]
Contains: 10629160000339
Package: case [30 Units]
In Commercial Distribution

FDA Product Code

BTCBag, Reservoir

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-11
Device Publish Date2024-03-01

Devices Manufactured by BOMImed Inc

20629160000305 - FEATHER-FLEX2024-03-113 LITRE DISPOSABLE LATEX FREE BREATHING BAG
20629160000305 - FEATHER-FLEX2024-03-11 3 LITRE DISPOSABLE LATEX FREE BREATHING BAG
20629160000015 - INTROES POCKET BOUGIE2021-08-16 INTROES POCKET BOUGIE - Endotracheal Tuber Introducer, 14FR (4.7mm) x 60cm
20629160000039 - BOMImed Saver 2021-08-16 BOMImed Disposable Saver Laryngoscope Blade
20629160000053 - BOMImed Saver 2021-08-16 BOMImed Disposable Saver Laryngoscope Blade
20629160012605 - AQUESURE FILTER HUMIDIFIER2019-05-28 Breathing circuit filter with built-in humidification

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