FDA.reportPublic FDA data

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

Primary DI
20848530082073
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
Rx
false
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
141668116
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Primary DI, Brand, Model table
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00848530109882CPAP FilterCF2111HA-10PL2026-09-30
00848530109899CPAP FilterCF2107HA-10PL2026-09-30
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00848530109912Nebulizer and CompressorACTNEB1002026-09-30
00848530109141Oxygen, Bacteria & HEPA FilterOF11003BR2026-06-30
00848530109165Oxygen, Bacteria & HEPA FilterOF11005BR2026-06-30
00848530109295Oxygen kitAATH006O2KIT2026-06-11
00848530109462Nasal CPAP MaskCM060-KITLNV2026-07-15
00848530109479Nasal CPAP MaskCM060L-NV2026-07-15
00848530109486Nasal CPAP MaskCM060XL-NV2026-07-15
00848530109523Oxygen KitAHOW001O2KIT2026-08-20
00848530109592Ventilator FilterVF010-12026-08-20
00848530109608Ventilator FilterVF010F-12026-08-20
00848530109639Nasal CPAP MaskCM060SNH2026-08-24
00848530109646Nasal CPAP MaskCM060MNH2026-08-24
00848530109653CPAP MaskCM061SNH2026-08-24
00848530109660CPAP MaskCM061MNH2026-08-24
00848530109691CPAP HeadgearHG060B2026-09-09
00848530109721OXYGEN CONNECTOR/ADAPTERRES019-1PL2026-09-09
00848530109738CPAP FilterCF1015NS2026-08-31

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
00848530082062Suction Catheter KitSunset Healthcare Solutions, Inc.OFS2018-07-31