FDA.report

BAG,2 LITER,NON-LATEX

Primary DI
00816711020868
Brand
BAG,2 LITER,NON-LATEX
Company
PARKER-HANNIFIN CORPORATION
Model
4100-2NL
Catalog number
4100-2NL
Device description
BAG,2 LITER,NON-LATEX
Published
2022-11-08
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
false

Related Records

Product Codes

CodeName
BTCBag, Reservoir

Product Code Classifications

CodeDeviceSpecialtyClass
BTCBag, ReservoirAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816711020868PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816711020868008167110208688167110208680816711020868

GMDN Terms

TermDefinition
Breathing circuit bag, reusableA 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 reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
004175550
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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