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
00848530107451Stratus Power SwitchRP0762025-09-24
00848530107468Stratus Pneumatic ValveRP0772025-09-24
00848530108984CPAP MaskCM206SNH2026-06-04
00848530108991CPAP MaskCM206MNH2026-06-04
00848530109004CPAP MaskCM206LNH2026-06-04
00848530109042CPAP MaskCM207SNH2026-06-04
00848530109059CPAP MaskCM207MNH2026-06-04
00848530109066CPAP MaskCM207LNH2026-06-04
00848530109080CPAP HeadgearHG2062026-06-04
00848530109103CPAP HeadgearHG2072026-06-04
00848530108328Repair PartsRP0932026-06-03
00848530109097CPAP MaskCM060S2026-06-03
00848530109264CPAP MaskCM060M2026-06-03
00848530109271CPAP MaskCM060L2026-06-03
00848530109288CPAP MaskCM060XL2026-06-03
00848530108953Repair PartsRP1082026-06-02
00848530108960Repair PartsRP1092026-06-02
00848530108977Repair PartsRP1102026-06-02
00848530109011Repair PartsRP1112026-06-02
00848530109028Repair PartsRP1122026-06-02

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