FDA.reportPublic FDA data

Silicone Suction Tubing Connector 10 grams 4.5in length 2.65mm wall thickness; O

Primary DI
00848530086404
Brand
Silicone Suction Tubing Connector 10 grams 4.5in length 2.65mm wall thickness; O
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
RES024M
Catalog number
RES024M
Device description
Silicone Suction Tubing Connector 10 grams 4.5in length 2.65mm wall thickness; OD 13.3mm
Published
2018-09-21
Public version status
Update
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
JOLCatheter And Tip, Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848530086401PackageGS110In Commercial Distribution
20848530086408PackageGS110In Commercial Distribution
00848530086404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853008640110848530086401
2084853008640820848530086408
00848530086404008485300864048485300864040848530086404

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). 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
Expiration date on label
true

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