FDA.reportPublic FDA data

Aspire Venting Tube Kit

Primary DI
10857808005891
Brand
Aspire Venting Tube Kit
Company
ASPIRE BARIATRICS, INC.
Model
100-0047
Catalog number
100-0047
Device description
Aspire Venting Tube Kit
Published
2019-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182248000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182248000Aspire Venting TubeAspire Bariatrics, Inc.2018-11-13KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857808005891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085780800589110857808005891

GMDN Terms#

Term, Definition table
TermDefinition
Gastrostomy tubeA thin, flexible, percutaneous, hollow tube which may include additional external components (e.g., external tubing, syringe) intended to be percutaneously inserted into the stomach to feed a patient with a physical disability that prevents oral feeding (e.g., a birth defect of the stomach), and/or provide drainage/decompression of the stomach when it is necessary to bypass an obstruction of the stomach outlet into the small intestine. Although noninvasive disposable enteral feeding components may be included, surgical instruments and pharmaceutical agents are not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-312-0007quality@aspirebariatrics.com

Regulatory Flags#

DUNS number
026281163
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10857808005419Aspire Introducer Needle100-0035100-00352018-08-13
10857808005013AspireAssist A-Tube Pack200-0044200-00442016-07-25
10857808005020AspireAssist A-Tube Kit100-0011-LANG A100-0011-LANG A2016-07-25
10857808005037AspireAssist A-Tube Kit100-0011-LANG B100-0011-LANG B2016-07-25
10857808005044AspireAssist A-Tube Kit100-0011-LANG C100-0011-LANG C2016-07-25
10857808005471AspireAssist A-Tube Kit100-0011-US100-0011-US2016-07-25
10857808005051AspireAssist Connector-LANG A200-0019-LANG A200-0019-LANG A2016-07-25
10857808005068AspireAssist Connector-LANG B200-0019-LANG B200-0019-LANG B2016-07-25
10857808005075AspireAssist Connector-LANG C200-0019-LANG C200-0019-LANG C 2016-07-25
10857808005082AspireAssist Reservoir 100-0012100-00122016-07-25
10857808005099AspireAssist Companion, Blue-LANG A100-0013-LANG A100-0013-LANG A2016-07-25
10857808005105AspireAssist Companion, Blue-LANG B100-0013-LANG B100-0013-LANG B 2016-07-25
10857808005112AspireAssist Companion, Blue-LANG C100-0013-LANG C100-0013-LANG C2016-07-25
10857808005129AspireAssist Companion, Magenta-LANG A100-0014-LANG A100-0014-LANG A2016-07-25
10857808005136AspireAssist Companion, Magenta-LANG B100-0014-LANG B100-0014-LANG B2016-07-25
10857808005143AspireAssist Companion, Magenta-LANG C100-0014-LANG C100-0014-LANG C2016-07-25
10857808005150AspireAssist Tubing Set100-0016100-00162016-07-25
10857808005167AspireAssist Starter Kit, Blue-LANG A100-0017-LANG A100-0017-LANG A2016-07-25
10857808005174AspireAssist Starter Kit, Blue-LANG B100-0017-LANG B100-0017-LANG B2016-07-25
10857808005181AspireAssist Starter Kit, Blue-LANG C100-0017-LANG C100-0017-LANG C2016-07-25

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