FDA.reportPublic FDA data

Tavish

Primary DI
50628725098598
Brand
Tavish
Company
Respan Products Inc
Model
R-9950S
Catalog number
R-9950S
Device description
MASK SMALL ADULT TAVISH NON REBRTHR OXYGEN ONE VALVE W/ 7' SAFLO OXYGEN
Published
2023-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGBMask, Oxygen, Non-Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGBMask, Oxygen, Non-RebreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50628725098598PackageGS125In Commercial Distribution
00628725098593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5062872509859850628725098598
00628725098593006287250985936287250985930628725098593

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
905-825 9300regulatory.affairs@chsltd.com

Regulatory Flags#

DUNS number
243175213
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50628725096983TavishR-7700SR-7700S2023-07-06
50628725097058Adult Nasal Cannula-Vinyl R-1701MR-1701M2023-07-06
5062872509726319mm Magenta Tubing Connector RPN-R-2980MRPN-R-2980M2023-07-06
50628725097010Pediatric Aerosol MaskR-2500R-25002023-06-30
50628725097027JemsdalA-251A-2512023-06-30
50628725098284TavishR-7200SR-7200S2023-06-30
50628725099489Adult Oxygen MaskR-2100R-21002023-06-30
50628725099793Pediatric High Concentration Oxygen MaskR-2750SR-2750S2023-06-30
50628725099809Pediatric Three-In-One MaskR-2755SR-2755S2023-06-30
50628725097256Corrugated TubingR-4020R-40202023-06-28
50628725097447Oxygen WrenchR-3040R-30402023-06-28
50628725098086Corrugated TubingR-4011-12R-4011-122023-06-28
50628725098192T-PieceR-6402R-64022023-06-28
50628725099540Adult Three-In-One Mask with 7' Saflo TubeR-2255SR-2255S2023-06-28
50628725099557Adult Three-In-One Mask with Multi-fit Connector on 7' Saflo TubeR-2255SMR-2255SM2023-06-28
50628725099564Adult Vari-Vent MaskR-2300SR-2300S2023-06-28
50628725097348Adult NSA Oxygen MaskR-9001R-90012023-06-27
50628725097393Security ChainR-3030R-30302023-06-27
50628725097409PPE CPAP Smoothbore TubingR-4420-72/50R-4420-72/502023-06-27
50628725097416Pediatric Aerosol MaskR-2500/50R-2500/502023-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09341394005242AeroShield CPR MaskAERO HEALTHCARE (US), LLCKGB2026-04-21
09341394027183AeroShield CPR Face ShieldAERO HEALTHCARE (US), LLCKGB2026-04-02
10197344009602HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344009619HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011476HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011483HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011506HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011810HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344042180HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344009609HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344009616HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011473HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011480HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011503HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011817HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
008171360277227450 RV2 MASKHANS RUDOLPH, INC.KGB2025-10-16
07045432118124Pocket Mask, PB (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432118223Pocket Mask, SP Blue (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432119145Pocket Mask, HC Yellow (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432118131Pocket Mask, PB (EN)Laerdal Medical ASKGB2025-08-25
07045432119183Pocket Mask, HC White Private LabelLaerdal Medical ASKGB2025-08-25
07045432119206Pocket Mask, SP Black Private LabelLaerdal Medical ASKGB2025-08-25
07045432119220Pocket Mask, SP Camo Private LabelLaerdal Medical ASKGB2025-08-25
07045432119152Pocket Mask O2, PB (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119169Pocket Mask O2, SP Blue (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119176Pocket Mask O2,HC Yellow (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119190Pocket Mask O2, HC White Private LabelLaerdal Medical ASKGB2025-07-29
07045432119213Pocket Mask O2, SP Black Private LabelLaerdal Medical ASKGB2025-07-29
07045432119237Pocket Mask O2, SP Camo Private LabelLaerdal Medical ASKGB2025-07-29
07045432119855Pocket Mask O2,HC Yellow (EN)Laerdal Medical ASKGB2025-07-29