FDA.reportPublic FDA data

Bag, Breathing, 3-Liter Latex Free

Primary DI
00817081023220
Brand
Bag, Breathing, 3-Liter Latex Free
Company
A-M SYSTEMS, LLC
Model
Bag, Breathing, 3-Liter Latex Free - 116301
Catalog number
116301
Device description
Bag, Breathing, 3-Liter Latex Free
Published
2019-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00817081023220PackageGS110In Commercial Distribution
00817081023213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817081023220008170810232208170810232200817081023220
00817081023213008170810232138170810232130817081023213

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3606838300sales@a-msystems.com

Regulatory Flags#

DUNS number
020275145
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817081028553VBMax28s, PF Testing Filter Labeled DR BurtonVBMax28s, DR Burton - VBMax28s1369042025-08-07
00817081028577VBMax28e, PF Testing Filter Labeled DR BurtonVBMax28e, DR Burton - VBMax28e1469042025-08-07
00817081028515VBMAX34, DISPOSABLE PF TESTING FILTERVBMAX34 - 1564002025-06-25
00817081028539PFT KIT J, VBMax34S w/ Blue Rubber Nose clipPFT KIT J, VBMax34S - 1871741871742025-06-25
00817081028492VBMax34, PF Testing Filter Labeled DR BurtonVBMax34, PF Testing Filter - 1564041564042025-06-03
00817081028478PFT Kit B, VBMax35PFT Kit B, VBMax35 - 1801141801142025-05-12
00817081028454PFT Kit J, VBMax31SPFT Kit J, VBMax31S - 1871411871412025-05-02
00817081028416VBMax28, PF Testing FilterVBMax28, PF Testing Filter - 1569041569042025-04-03
00817081028430PFT Kit B, VBMax35 w/ Blue Foam Nose clipPFT Kit B, VBMax35 - 1801151801152025-04-03
00817081028393PFT Kit I, VBMax36S w/ Foam Nose Clip and 164900PFT Kit I, VBMax36S - 1872661872662025-04-02
00817081028379PFT Kit B, VBMax48PFT Kit B, VBMax48 - 1881021881022025-03-24
00817081028355Pulmonary Function Test Kit EPulmonary Function Test Kit E - 1891241891242025-02-28
00817081028270PFT Kit E, VBMax36E PFT Kit E, VBMax36E - 1891391891392025-02-25
00817081028294Disposable White PFT Nose Clip with Rubber Pads, Labeled D R BurtonDisposable White PFT Nose Clip with Rubber Pads - 1660042025-02-25
00817081028317Disposable Blue PFT Nose Clip with Rubber PadsDisposable Blue PFT Nose Clip - 1667041667042025-02-25
00817081028331Disposable Blue PFT Nose Clip with Foam PadsDisposable Blue PFT Nose Clip with Foam Pads - 1661669042025-02-25
00817081028232Mouthpiece, Disposable, White, Thermoplastic, Bite Block StyleDisposable Mouthpiece, Bite Block Style - 1649041649042025-02-21
00817081028256Breathebite Mouthpiece, Disposable, Thermoplastic, Tongue DepressingBreathebite Mouthpiece - 1649541649542025-02-21
00817081028218PFT Nose Clip with Foam PadsPFT Nose Clip with Foam Pads1665042025-02-20
00817081028195Pulmonary Function Test Kit EPFT Kit E - 1891251891252025-02-18

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