FDA.reportPublic FDA data

Silicone Suction Tubing Connector

Primary DI
00848530087944
Brand
Silicone Suction Tubing Connector
Company
Sunset Healthcare Solutions, Inc.
Model
RES024L10
Catalog number
RES024L10
Device description
Silicone Suction Tubing Connector. 10in Length, 2.65mm Wall Thickness, 13.3mm OD
Published
2018-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
10848530087941PackageGS110In Commercial Distribution
20848530087948PackageGS110In Commercial Distribution
00848530087944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853008794110848530087941
2084853008794820848530087948
00848530087944008485300879448485300879440848530087944

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.

Contacts#

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

Regulatory Flags#

DUNS number
141668116
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00848530109592Ventilator FilterVF010-12026-08-20
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00848530109646Nasal CPAP MaskCM060MNH2026-08-24
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00848530109660CPAP MaskCM061MNH2026-08-24
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00848530109820Ventilation AccessoryVEN008NS2026-09-09
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