FDA.report

LATEX FREE RUBBER BREATHING BAG 2.0L

Primary DI
04716770622200
Brand
LATEX FREE RUBBER BREATHING BAG 2.0L
Company
BESMED HEALTH BUSINESS CORP.
Model
BR-62220
Device description
LATEX FREE RUBBER BREATHING BAG 2.0L
Published
2017-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
BTCBag, Reservoir

Product Code Classifications

CodeDeviceSpecialtyClass
BTCBag, ReservoirAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04716770622200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04716770622200047167706222004716770622200

GMDN Terms

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

Regulatory Flags

DUNS number
658023775
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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