FDA.reportPublic FDA data

Suction Catheter Kit

Primary DI
00848530082062
Brand
Suction Catheter Kit
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
TRATK108
Catalog number
TRATK108
Device description
This kit includes: 1 Catheter - 8Fr, Y-Valve, 1 Pair gloves - One size fits most.
Published
2018-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OFSTracheal Suction Set

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFSTracheal Suction SetAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848530082069PackageGS150In Commercial Distribution
20848530082066PackageGS14In Commercial Distribution
00848530082062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853008206910848530082069
2084853008206620848530082066
00848530082062008485300820628485300820620848530082062

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy suction kitA collection of sterile devices and supplies intended to suction secretions from the trachea and bronchi through a tracheostomy tube. It typically includes a tracheal suctioning catheter with an appropriate tip (e.g., a whistle tip for adults, a smaller one for children) and a thumb operated valve, a pair of gloves, and a container for the aspirates. It is typically intended to be used with a suction machine. Some types include an inner cannula replacement for the tracheostomy tube. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-578-6738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530060725Bubble Humidifiers - 6psiRES050RES0502018-07-31
00848530060732Bubble Humidifiers - 6psiRES050-50RES050-502018-07-31
00848530062064Bubble Humidifiers - 6psiRES050-1RES050-12018-07-31
00848530108557CPAP FilterCF1013-22026-08-26
00848530090890Zoey CPAP CleanerZCD100ZCD1002020-02-28
00848530106430Heat Moisture ExchangerRES027SG2026-08-15
00848530109677CPAP Mask KitCM061-KITS2026-08-15
00848530109684CPAP Mask KitCM061-KITL2026-08-15
00848530109455Oxygen AccessoryRES031M-12026-07-23
00848530109509Ventilator FilterVIVOFILTERKIT2026-07-23
00848530109516CPAP FilterCF40042026-07-23
00848530109127Oxygen, Bacteria & HEPA FilterOF1001BR2026-06-23
00848530109134Oxygen, Bacteria & HEPA FilterOF1005BR2026-06-23
00848530109172Oxygen, Bacteria & HEPA FilterOF11006BR2026-06-23
00848530109189Oxygen, Bacteria & HEPA FilterOF3002BR2026-06-23
00848530109196Oxygen, Bacteria & HEPA FilterOF5001BR2026-06-23
00848530109202Oxygen, Bacteria & HEPA FilterOF6001BR2026-06-23
00848530109219Oxygen, Bacteria & HEPA FilterOF8002BR2026-06-23
00848530109226Oxygen, Bacteria & HEPA FilterOF9001BR2026-06-23
00848530109233Oxygen, Bacteria & HEPA FilterOF9002BR2026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530082079Suction Catheter Kit - Sterile - Includes Gloves, Catheter - 10FrSUNSET HEALTHCARE SOLUTIONS, INC.OFS2018-09-17
20848530082073Suction Catheter Kit - Sterile - Includes Gloves, Catheter - 10FrSUNSET HEALTHCARE SOLUTIONS, INC.OFS2018-09-17