FDA.reportPublic FDA data

Sunset Healthcare Solutions Silicone Suction Tubing Connector - 3.5in

Primary DI
00848530060428
Brand
Sunset Healthcare Solutions Silicone Suction Tubing Connector - 3.5in
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
RES024
Catalog number
RES024
Device description
Silicone Suction Tubing Connector 10 grams 3.5in in length 2.65mm wall thickness; OD 13.3mm
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAZTubing, Noninvasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848530060425PackageGS110In Commercial Distribution
20848530060422PackageGS110In Commercial Distribution
00848530060428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853006042510848530060425
2084853006042220848530060422
00848530060428008485300604288485300604280848530060428

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 (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.5Inch
Lumen/Inner Diameter8Millimeter
Outer Diameter13.3Millimeter

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
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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00848530108977Repair PartsRP1102026-06-02
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00848530109028Repair PartsRP1122026-06-02

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