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

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00848530109134Oxygen, Bacteria & HEPA FilterOF1005BR2026-06-23
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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
00848530109240Oxygen, Bacteria & HEPA FilterOF9004BR2026-06-23
00848530109257Oxygen, Bacteria & HEPA FilterBF2200BR2026-06-23
00848530109110Suction KitRES026S-KITC2026-06-10
00848530107451Stratus Power SwitchRP0762025-09-24

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