FDA.report

VentStar Breathing Bag 1L

Primary DI
04048675441700
Brand
VentStar Breathing Bag 1L
Company
Drägerwerk AG & Co. KGaA
Model
MP02711
Published
2016-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BTCBag, Reservoir

Product Code Classifications

CodeDeviceSpecialtyClass
BTCBag, ReservoirAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048675441700PackageGS125In Commercial Distribution
04048675389453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048675441700040486754417004048675441700
04048675389453040486753894534048675389453

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

Contacts

PhoneEmail
+494518820INFO@DRAEGER.COM

Regulatory Flags

DUNS number
315578914
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
false
Sterilization required before use
false

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