FDA.reportPublic FDA data

BAG,3 LITER,NON-LATEX

Primary DI
00816711020851
Brand
BAG,3 LITER,NON-LATEX
Company
PARKER-HANNIFIN CORPORATION
Model
4100-3NL
Catalog number
4100-3NL
Device description
BAG,3 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

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
00816711020851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816711020851008167110208518167110208510816711020851

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
004175550
Device count
1
Premarket exempt
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816711024972MATRX SCAV(WO/HOOD)WO/SHUTOFF91515197915151972026-02-23
00816711020097ANALGESIA GAS MIXER, DIGITAL MDM DELIVERY SYSTEM40151601 KOR2025-09-24
00816711020424NITRONOX SCAVENGERNOX-53002025-09-24
00816711024958PORTER,MED BR CIR,6FT,20PCKDMC-12-6DMC-12-62025-09-17
00816711024965PORTER,MED BR CIR,10FT,20PCKDMC-12-10DMC-12-102025-09-17
00816711024941HOSE N2O DISS/DISS 8 FT850885082025-02-27
00816711024224SCAVENGER, EAVS, MIDASEAVS-5000EAVS-50002025-02-21
00816711024927DEMAND VALVE, POS PR., DISS1506-1D1506-1D2025-02-21
00816711024934HA,O2,INTL (DISSF X DISSF)2FT92305297-2 92305297-2 2025-02-21
00816711024439DIGITAL MDM ASSY-120V(STAND MT40151602 915251152024-04-05
00816711023821Digital MDM, 30% Std ISO40151602 915251762023-09-05
00816711023838DIGITAL MDM 30% GERMANY91525178915251782023-09-05
00816711023845INTL DMDM (STAND)-SPAIN91525179915251792023-09-05
00816711023852INTL DMDM 40% STAND-SWEDEN91525180915251802023-09-05
00816711023869INTL DMDM (STAND)-ISRAEL91525182915251822023-09-05
00816711023876INTL DMDM,STANDARD-AUSTRALIA91525184915251842023-09-05
00816711023883INTL DMDM (STAND)-DUTCH91525185915251852023-09-05
00816711023890INTL DMDM (STAND)-CANADA91525186915251862023-09-05
00816711023906INTL DMDM,CABINET MOUNT91525187915251872023-09-05
00816711023913INTL DMDM 30%(STAND)-ITALY91525262915252622023-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08697645018198ENDURE INDUSTRIESENDURE INDUSTRIESBTC2026-04-17
10889483560952Vital Signs™SUNMED, LLCBTC2025-12-31
10889483560945Vital Signs™SUNMED, LLCBTC2025-12-30
10889483560938Vital Signs™SUNMED, LLCBTC2025-12-19
10885632455438Halyard Breathing BagAIRLIFEBTC2025-07-25
10885632455414Halyard Breathing BagAIRLIFEBTC2025-07-18
10885632455421Halyard Breathing BagAIRLIFEBTC2025-07-18
10629160000346FEATHER-FLEXBOMImed IncBTC2025-07-14
10889483601709Vital Signs™AirLife Finland OyBTC2025-04-01
10889483601716Vital Signs™AirLife Finland OyBTC2025-04-01
10889483601723Vital Signs™AirLife Finland OyBTC2025-04-01
10889483584804Vital Signs™AIRLIFEBTC2025-03-06
10889483584828Vital Signs™AIRLIFEBTC2025-03-06
10629160000339FEATHER-FLEXBOMImed IncBTC2024-03-01
10080196984190Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984213Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984251Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984770Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984787Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984848Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984855Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984916Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984930Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389001943Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389004999Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389005002Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389380932Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389382615Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389447048Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389447093Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04