FDA.reportPublic FDA data

FEATHER-FLEX

Primary DI
10629160000346
Brand
FEATHER-FLEX
Company
BOMImed Inc
Model
2L
Catalog number
OL-649502-00/NSP0204
Device description
2 LITRE DISPOSABLE LATEX FREE BREATHING BAG
Published
2025-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTCBag, Reservoir

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTCBag, ReservoirAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20629160000350PackageGS130In Commercial Distribution
10629160000346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2062916000035020629160000350
1062916000034610629160000346

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit bag, single-useA non-sterile elastomeric reservoir sac intended to store breathing gas during the respiratory cycle. The breathing bag may be on the inspiratory or expiratory limb of a breathing circuit depending on the breathing circuit design. It may also function as a maximum pressure limiting device during spontaneous or manually assisted ventilation. It may be made of conductive or non-conductive material and is typically used in anaesthesia or ventilator breathing circuits. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
204-633-2664regulatory@bomimed.com

Regulatory Flags#

DUNS number
248200149
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10629160000049BOMImed SaverMAC 3OL-33132025-08-08
20629160000046BOMImed SaverMAC 3OL-33132025-08-08
20629160000350FEATHER-FLEX2LOL-649502-00/NSP02042025-07-14
10629160000339FEATHER-FLEX3LOL-649503-00/NSP02032024-03-01
20629160000305FEATHER-FLEX3LOL-649503-00/NSP02032024-03-01
10629160012608AQUESURE FILTER HUMIDIFIEROL-040419-U00OL-040419-U002016-09-26
10629160000018INTROES POCKET BOUGIEOL-E12102OL-E121022021-08-06
10629160000032BOMImed Saver MAC 2OL-33122021-08-06
10629160000056BOMImed Saver MAC 4OL-33142021-08-06
20629160000015INTROES POCKET BOUGIEOL-E12102OL-E121022021-08-06
20629160000039BOMImed Saver MAC 2OL-33122021-08-06
20629160000053BOMImed Saver MAC 4OL-33142021-08-06
20629160012605AQUESURE FILTER HUMIDIFIEROL-040419-U00OL-040419-U002016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501430BREATHING BAG single use 500ASSOMEDIKA, OOOBTC2026-05-27
04816415501447BREATHING BAG single use 1000ASSOMEDIKA, OOOBTC2026-05-27
04816415501454BREATHING BAG single use 2000ASSOMEDIKA, OOOBTC2026-05-27
04816415501461BREATHING BAG single use 3000ASSOMEDIKA, OOOBTC2026-05-27
04816415501478BREATHING BAG reusable 500ASSOMEDIKA, OOOBTC2026-05-27
04816415501485BREATHING BAG reusable 1000ASSOMEDIKA, OOOBTC2026-05-27
04816415501492BREATHING BAG reusable 2000ASSOMEDIKA, OOOBTC2026-05-27
04816415501508BREATHING BAG reusable 3000ASSOMEDIKA, OOOBTC2026-05-27
08697645018198ENDURE INDUSTRIESENDURE INDUSTRIESBTC2026-04-17
10889483560938Vital Signs™SUNMED, LLCBTC2025-12-19
10885632455438Halyard Breathing BagAIRLIFEBTC2025-07-25
10885632455414Halyard Breathing BagAIRLIFEBTC2025-07-18
10885632455421Halyard Breathing BagAIRLIFEBTC2025-07-18
10629160000339FEATHER-FLEXBOMImed IncBTC2024-03-01
10080196984190Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984213Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984251Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984770Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984787Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984848Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984855Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984916Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984930Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389001943Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389004999Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
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10884389380932Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389382615Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389447048Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389447093Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04