FDA.reportPublic FDA data

RUSCH

Primary DI
14026704929419
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN930486
Catalog number
8011
Device description
ISO - GARD CLEAR AIR MASK, WITH TUBING
Published
2025-10-22
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
34026704929413PackageGS120In Commercial Distribution
14026704929419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3402670492941334026704929413
1402670492941914026704929419

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
Kit
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902167344ARROWIPN916986CA-22123-F2026-07-30
10801902190908ARROWIPN919754CC-04100-S2026-07-30
10801902192933ARROWIPN920077CDA-25122-U1A2026-07-30
10801902193114ARROWIPN920089CDC-29803-XCN1A2026-07-30
10801902193121ARROWIPN920090CDC-29803-XN1A2026-07-30
10801902193190ARROWIPN920097CDC-29903-XCN1A2026-07-30
10801902193206ARROWIPN920098CDC-29903-XN1A2026-07-30
10801902193527ARROWIPN920130CS-15242-SPM2026-07-30
10801902193619ARROWIPN920140CS-15232-VFIM2026-07-30
10801902193626ARROWIPN920141CS-15232-VF2026-07-30
10801902193633ARROWIPN920142CS-15232-VFM2026-07-30
10801902193688ARROWIPN920131CS-15282-SPM2026-07-30
10801902194463ARROWIPN920404CS-15232-VFI2026-07-30
10801902196184ARROWIPN920629EI-040602026-07-30
10801902196498ARROWIPN920660CDC-21142-XCN1A2026-07-30
10801902196511ARROWIPN920662CDC-21242-XCN1A2026-07-30
10801902196528ARROWIPN920663CDC-21242-XN1A2026-07-30
10801902197716ARROWIPN920778JC-05400-E2026-07-30
10801902198461ARROWIPN920836PW-18080-HN2026-07-30
10801902200768ARROWIPN921145CL-078352026-07-30

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
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
14026704916648HUDSON RCITELEFLEX INCORPORATEDCBN2024-01-23
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