FDA.reportPublic FDA data

Aspire Introducer Needle

Primary DI
10857808005419
Brand
Aspire Introducer Needle
Company
ASPIRE BARIATRICS, INC.
Model
100-0035
Catalog number
100-0035
Device description
Introducer Needle
Published
2018-08-13
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

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
K180725000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180725000Aspire Introducer NeedleAspire Bariatrics, Inc.2018-07-11KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857808005419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085780800541910857808005419

GMDN Terms#

Term, Definition table
TermDefinition
Non-vascular catheter introduction setA collection of invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter); it is not intended for introduction of a peritoneal dialysis catheter. It includes multiple invasive access devices which typically include an introducer needle, introducer sheath with an inner dilator, and guidewire; the catheter is not included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Centimeter
Needle Gauge17Gauge

Sterilization Methods#

Method table
Method

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
10857808005891Aspire Venting Tube Kit100-0047100-00472019-01-25
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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Primary DI, Brand, Company table
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10192253006858Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006865Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253011449CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011463CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011487CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011517CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011531CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011555CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011579CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011593CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011616CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
08015262035662NUTRIFITPENTAFERTE ITALIA SRLKNT2025-07-03
10192253011128KangarooCardinal Health 200, LLCKNT2025-05-28
10192253011159CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011173CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011197CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011227CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011258CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011272CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011296CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011630CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011104KangarooCardinal Health 200, LLCKNT2025-01-14
G461EGCT36M0EndolumikEndolumik, Inc.KNT2024-08-06
G461EGCT40M0EndolumikEndolumik, Inc.KNT2024-08-06
10192253011319KangarooCardinal Health 200, LLCKNT2024-06-13
10192253011326KangarooCardinal Health 200, LLCKNT2024-06-13
10192253011333KangarooCardinal Health 200, LLCKNT2024-06-13