FDA.report

RESERVOIR BAG, 3L WITH ANTI OCCLUSION CAGE MOUNT, 22F NECK

Primary DI
05030267012084
Brand
RESERVOIR BAG, 3L WITH ANTI OCCLUSION CAGE MOUNT, 22F NECK
Company
INTERSURGICAL INCORPORATED
Model
2830000
Device description
RESERVOIR BAG, 3L WITH ANTI OCCLUSION CAGE MOUNT, 22F NECK
Published
2021-10-15
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

Related Records

Contact Domains

Product Codes

CodeName
BTCBag, Reservoir

Product Code Classifications

CodeDeviceSpecialtyClass
BTCBag, ReservoirAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05030267012084PackageGS110In Commercial Distribution
05030267012091PackageGS140In Commercial Distribution
05030267065165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05030267012084050302670120845030267012084
05030267012091050302670120915030267012091
05030267065165050302670651655030267065165

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
3154512900support@intersurgicalinc.com

Regulatory Flags

DUNS number
785952607
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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