FDA.reportPublic FDA data

Suction Catheter Kit - Sterile - Includes Gloves, Catheter - 10Fr

Primary DI
00848530082079
Brand
Suction Catheter Kit - Sterile - Includes Gloves, Catheter - 10Fr
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
TRATK110
Catalog number
TRATK110
Device description
Suction Catheter Kit - Sterile - Includes Gloves, Catheter - 10Fr
Published
2018-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
10848530082076PackageGS150In Commercial Distribution
20848530082073PackageGS14In Commercial Distribution
00848530082079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853008207610848530082076
2084853008207320848530082073
00848530082079008485300820798485300820790848530082079

GMDN Terms#

Term, Definition table
TermDefinition
Secretion suction kitA collection of items intended for suctioning secretions from a patient; typically included are sterile gloves, a suction catheter, and a container for collecting the secretions. This is a single-use device.

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
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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
20848530082073Suction Catheter Kit - Sterile - Includes Gloves, Catheter - 10FrSUNSET HEALTHCARE SOLUTIONS, INC.OFS2018-09-17
00848530082062Suction Catheter KitSUNSET HEALTHCARE SOLUTIONS, INC.OFS2018-07-31