FDA.reportPublic FDA data

KIT-BAG TEE/SCAV SWIVEL ASSY

Primary DI
00816711020790
Brand
KIT-BAG TEE/SCAV SWIVEL ASSY
Company
PARKER-HANNIFIN CORPORATION
Model
91525135
Catalog number
91525135
Device description
KIT-BAG TEE/SCAV SWIVEL ASSY
Published
2022-11-07
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

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
00816711020790PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816711020790008167110207908167110207900816711020790

GMDN Terms#

Term, Definition table
TermDefinition
Non-rebreathing valve, reusableA non-sterile device that is a one-way valve used to direct the flow of breathing gases and prevent the patient rebreathing the exhaled gases. It is typically used in a breathing system or between an oxygen mask and its reservoir bag. The device may be of various designs and will typically include unidirectional valves made of, e.g., silicone, rubber, metal, mica, sheets or discs that open and close for each inspiration/expiration. This is a reusable device.

Sterilization Methods#

Method table
Method

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
false
Sterilization required before use
false

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
00816711024231MIDAS, REMOTE, 70%-W-O2 AUS615161512024-10-14
00816711024248MIDAS, REMOTE, 70%-W-N20 AUS618161812024-10-14
00816711024255MIDAS, REMOTE, 60%-W-O2, SWE614261422024-10-14
00816711024262MIDAS, REMOTE, 60%-W-N2O SWE617261722024-10-14
00816711024279MIDAS, REMOTE, 50%-W-O2613061302024-10-14
00816711024286MIDAS, REMOTE, 60%-W-O2614061402024-10-14
00816711024293MIDAS, REMOTE, 70%-W-O2615061502024-10-14
00816711024309MIDAS, REMOTE, 50%-W-N2O616061602024-10-14
00816711024316MIDAS, REMOTE, 60%-W-N2O617061702024-10-14
00816711024323MIDAS, REMOTE, 70%-W-N20 618061802024-10-14
00816711024330MIDAS, PORTABLE, 70%-W-O2 AUS605160512024-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06923980111907MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112614MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112621MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112638MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112805MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112829MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
20889483560959Vital Signs™SUNMED, LLCBTC2025-12-31
20889483560942Vital Signs™SUNMED, LLCBTC2025-12-30
20889483560935Vital Signs™SUNMED, LLCBTC2025-12-19
20885632455435Halyard Breathing BagAIRLIFEBTC2025-07-25
20885632455411Halyard Breathing BagAIRLIFEBTC2025-07-18
20885632455428Halyard Breathing BagAIRLIFEBTC2025-07-18
10889483642412Vital Signs Breathing BagAIRLIFEBTC2025-07-18
10889483642429Vital Signs Breathing BagAIRLIFEBTC2025-07-18
10889483642436Vital Signs Breathing BagAIRLIFEBTC2025-07-18
10889483642443Vital Signs Breathing BagAIRLIFEBTC2025-07-18
20629160000350FEATHER-FLEXBOMImed IncBTC2025-07-14
46923980115552MindrayGaleMed Xiamen Co., Ltd.BTC2025-06-23
10889483602492Vital Signs™AirLife Finland OyBTC2025-04-04
20889483601706Vital Signs™AirLife Finland OyBTC2025-04-01
20889483601713Vital Signs™AirLife Finland OyBTC2025-04-01
20889483601720Vital Signs™AirLife Finland OyBTC2025-04-01
20889483601737Vital Signs™AirLife Finland OyBTC2025-04-01
20889483620073Vital Signs™AirLife Finland OyBTC2025-04-01
20889483602505Vital Signs™AirLife Finland OyBTC2025-03-28
20889483602512Vital Signs™AirLife Finland OyBTC2025-03-28
30889483584808Vital Signs™Sunmed Group Holdings, LLCBTC2025-03-06
30889483584822Vital Signs™Sunmed Group Holdings, LLCBTC2025-03-06
06972249260085Breathing bagsShandong Jinlai Huanhai Medical Technology Co., Ltd.BTC2025-03-03
06972249260092Breathing bagsShandong Jinlai Huanhai Medical Technology Co., Ltd.BTC2025-03-03