FDA.reportPublic FDA data

Suction Kit with XL Tube

Primary DI
00848530081669
Brand
Suction Kit with XL Tube
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
RES026-EXL
Catalog number
RES026-EXL
Device description
This Kit Contains: 1 RES023 Suction Canister, 1 RES024XL Suction Tubing Connector - 16in, 1 RES025 Suction Tubing - 6ft, 1 RES028 Elbow Connector, 1 BF3812 Bacteria Filter.
Published
2018-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530081669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530081669008485300816698485300816690848530081669

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

Contacts#

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

Regulatory Flags#

DUNS number
141668116
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

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00848530108960Repair PartsRP1092026-06-02
00848530108977Repair PartsRP1102026-06-02
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00848530109028Repair PartsRP1122026-06-02