FDA.reportPublic FDA data

HUDSON RCI

Primary DI
14026704916648
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN928017
Catalog number
8013
Device description
ISO-GARD CLEAR AIR MASK, WYE & CLAMPS
Published
2024-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBNAPPARATUS, GAS-SCAVENGING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBNApparatus, Gas-ScavengingAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704916645PackageGS120In Commercial Distribution
04026704582099PreviousGS10
14026704916648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670491664524026704916645
04026704582099040267045820994026704582099
1402670491664814026704916648

GMDN Terms#

Term, Definition table
TermDefinition
Rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is made of non-conductive, soft, flexible polymers available in a range of sizes, and designed to create an airtight seal against the patient's face. The device may include tubing and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery; other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801902003362ARROWIPN035388CC-017002026-08-03
00850921007417ARROWIPN919634DLX-200-USC2026-08-03
04026704916955RUSCHIPN9007315640002026-08-03
04026704934812TELEFLEXIPN931133ST192026-08-03
05060112310058LMA AIRWAY MANAGEMENTIPN9016471000152026-08-03
05060112310065LMA AIRWAY MANAGEMENTIPN9016491000202026-08-03
05060112310607LMA AIRWAY MANAGEMENTIPN9018611500152026-08-03
10801902170191ARROWIPN917307CS-017012026-08-03
10801902206241ARROWIPN922981PW-18080-HS2026-08-03
10801902215168ARROWIPN9280309001T-VC-0052026-08-03
10801902219210ARROWIPN929382CV-15123-F2026-08-03
10801902226416ARROWIPNB00521ASK-21242-UR32026-08-03
14026704730466PILLINGIPN924356P358PRA2026-08-03
14026704934758LMA AIRWAY MANAGEMENTIPN9292541360652026-08-03
14026704934765LMA AIRWAY MANAGEMENTIPN9292561360752026-08-03
14026704934772LMA AIRWAY MANAGEMENTIPN9292571360802026-08-03
14026704934802LMA AIRWAY MANAGEMENTIPN9292551360702026-08-03
00801902004857ARROWIPN033843AK-040202016-09-16
05060112310041LMA AIRWAY MANAGEMENTIPN9016451000102026-07-31
05060112310621LMA AIRWAY MANAGEMENTIPN9018661500252026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858545007110Sovant Cannula with Microstream AdapterDYNASTHETICS, LLCCBN2026-07-29
00858545007127Sovant VeyO2 mask with Microstream adapterDYNASTHETICS, LLCCBN2026-07-29
00858545007134Sovant VeyO2 mask with Microstream adapterDYNASTHETICS, LLCCBN2026-07-29
14026704929419RUSCHTELEFLEX INCORPORATEDCBN2025-10-22
14026704929426RUSCHTELEFLEX INCORPORATEDCBN2025-10-22
14026704929433RUSCHTELEFLEX INCORPORATEDCBN2025-10-22
14026704929440RUSCHTELEFLEX INCORPORATEDCBN2025-10-22
00816711020424NITRONOX SCAVENGERPARKER-HANNIFIN CORPORATIONCBN2025-09-24
00860013652302DemistifierPeace Medical IncCBN2025-08-12
00816711024224SCAVENGER, EAVS, MIDASPARKER-HANNIFIN CORPORATIONCBN2025-02-21
00858545007035SmartProngs CannulaDYNASTHETICS, LLCCBN2024-09-24
00858545007042VeyO2 MaskDYNASTHETICS, LLCCBN2024-09-24
00858545007028SovantDYNASTHETICS, LLCCBN2024-09-24
10858545007032SmartProngs CannulaDYNASTHETICS, LLCCBN2024-09-24
10858545007049VeyO2 MaskDYNASTHETICS, LLCCBN2024-09-24
14026704916655HUDSON RCITELEFLEX INCORPORATEDCBN2024-01-23
24026704916645HUDSON RCITELEFLEX INCORPORATEDCBN2024-01-23
24026704916652HUDSON RCITELEFLEX INCORPORATEDCBN2024-01-23
00813830021066FRU, Vacuum Connector With BarbsACCUTRON, INC.CBN2023-10-05
00813830022094Accutron Vacuum Male ConnectorACCUTRON, INC.CBN2023-10-05
00813830026856FRU, Axess Vacuum GaugeACCUTRON, INC.CBN2023-10-05
00813830027839FRU, 4 Cylinder Remote Vacuum KitACCUTRON, INC.CBN2023-10-05
00813830027181FRU, Axess Scavenging Control, In-LineACCUTRON, INC.CBN2023-10-02
00813830027327FRU, Axess To Accuvac AdaptorACCUTRON, INC.CBN2023-10-02
00813830027433Axess 90 Deg Outspout ConnectorACCUTRON, INC.CBN2023-10-02
00813830027518White Axess, RFS CircuitACCUTRON, INC.CBN2023-09-21
00813830027525White Axess In-Line CircuitACCUTRON, INC.CBN2023-09-21
00813830027716ClearView Capnography AdaptersACCUTRON, INC.CBN2023-09-14
14026704734198HUDSON RCITELEFLEX INCORPORATEDCBN2023-09-12
14026704734204HUDSON RCITELEFLEX INCORPORATEDCBN2023-09-12