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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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.

Contacts#

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

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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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