FDA.reportPublic FDA data

Elite HV Transitionless Hemostasis Valve Introducer Kit

Primary DI
00841268103580
Brand
Elite HV Transitionless Hemostasis Valve Introducer Kit
Company
GALT MEDICAL CORP.
Model
CLI-109-45
Catalog number
CLI-109-45
Device description
Elite HV Transitionless Hemostasis Valve Introducer Kit
Published
2018-03-01
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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841268103587PackageGS110In Commercial Distribution
20841268103584PackageGS1100In Commercial Distribution
00841268103580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084126810358710841268103587
2084126810358420841268103584
00841268103580008412681035808412681035800841268103580

GMDN Terms#

Term, Definition table
TermDefinition
Haemostasis valveA noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a self-sealing lumen(s) [e.g., Touhy-Borst valve] and sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer). It is not designed to be connected between tubing (i.e., not an in-line valve). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge4French

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
800-639-2800customerservice@galtneedletech.com

Regulatory Flags#

DUNS number
943156836
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841268110397Transcarotid/Peripheral Access KitKIT-075-05KIT-075-052026-08-18
00841268100855GuidewireSGW-019-38SGW-019-382017-07-03
00841268100862GuidewireSGW-019-40SGW-019-402017-07-03
00841268100879GuidewireSGW-019-41SGW-019-412017-07-03
00841268100886GuidewireSGW-019-52SGW-019-522017-07-03
00841268100893GuidewireSGW-019-53SGW-019-532017-07-03
00841268100909GuidewireSGW-021-02SGW-021-022017-07-03
00841268100916GuidewireSGW-021-03SGW-021-032017-07-03
00841268100923GuidewireSGW-021-04SGW-021-042017-07-03
00841268100930GuidewireSGW-022-09SGW-022-092017-07-03
00841268100947GuidewireSGW-022-10SGW-022-102017-07-03
00841268100954GuidewireSGW-022-11SGW-022-112017-07-03
00841268100961GuidewireSGW-022-13SGW-022-132017-07-03
00841268100978GuidewireSGW-022-14SGW-022-142017-07-03
00841268100985GuidewireSGW-022-15SGW-022-152017-07-03
00841268100992GuidewireSGW-022-16SGW-022-162017-07-03
00841268101005GuidewireSGW-022-32SGW-022-322017-07-03
00841268101012GuidewireSGW-022-33SGW-022-332017-07-03
00841268101029GuidewireSGW-022-36SGW-022-362017-07-03
00841268101036Guidewire SGW-022-49SGW-022-492017-07-03

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