FDA.reportPublic FDA data

Corrugated Tubing

Primary DI
50628725097430
Brand
Corrugated Tubing
Company
Respan Products Inc
Model
R-4000
Catalog number
R-4000
Device description
TUBING 22MM AEROSOL CORRUGATED
Published
2023-06-26
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
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50628725097430PackageGS11In Commercial Distribution
00628725097435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5062872509743050628725097430
00628725097435006287250974356287250974350628725097435

GMDN Terms#

Term, Definition table
TermDefinition
Vacuum hoseA length of reinforced colour-coded flexible tubing intended to be connected to a vacuum-producing medical device, medical equipment, or a medical system to channel incoming suction. It has a thick wall to prevent collapse due to the negative pressure of the vacuum and typically produced according to ISO5359. It is available in various lengths, including standard coil lengths. This is a reusable 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
00848530087142Respiratory AccessorySunset Healthcare Solutions, Inc.BYX2025-11-19
00848530070236CPAP TubingSunset Healthcare Solutions, Inc.BYX2025-05-19
00848530070281CPAP TubingSunset Healthcare Solutions, Inc.BYX2025-05-19
00789091681564Oxygen TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00789091681595CPAP TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00789091681601CPAP TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00848530089375Suction KitSunset Healthcare Solutions, Inc.BYX2025-04-15
00848530094232AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094256AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094263AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094270AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094294AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094317AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094331AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094348AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094355AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094362AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094379AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094386AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094393AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094409AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094416AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094423AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094430AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094447AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094454AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094461AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094478AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094485AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094492AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07