FDA.reportPublic FDA data

Amniocentesis Tray

Primary DI
00886333220809
Brand
Amniocentesis Tray
Company
ARGON MEDICAL DEVICES, INC.
Model
A4545ASP
Catalog number
A4545ASP
Device description
Amniocentesis Tray with Safety Devices and 20ga x 8.9cm Needle
Published
2022-07-20
Public version status
Update
Distribution status
Not 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
HIOSampler, Amniotic Fluid (Amniocentesis Tray)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIOSampler, Amniotic Fluid (Amniocentesis Tray)Obstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333220803PackageGS110Not in Commercial Distribution
00886333220809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633322080320886333220803
00886333220809008863332208098863332208090886333220809

GMDN Terms#

Term, Definition table
TermDefinition
Amniocentesis kit, medicated, single-useA collection of sterile devices designed to aspirate and contain a sample of amniotic fluid from the amniotic sac, via a transabdominal approach, for analysis. Components typically include a needle with stylet and syringe, specimen containers/medium, drapes, dressings, and pharmaceuticals. The device is typically used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities (e.g., Down syndrome, spina bifida), or anytime after 24-weeks gestation to assess foetal maturity. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
140727624
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886333226931Micro-Access Introducer4978374978372026-10-07
00886333226948Micro-Access Introducer4978394978392026-10-07
00886333004171V•Stick™ Vascular Access Set390204400E390204400E2016-09-16
00886333004188V•Stick™ Vascular Access Set391504000E391504000E2016-09-16
00886333004195V•Stick™ Vascular Access Set391504300E391504300E2016-09-16
00886333004201V•Stick™ Vascular Access Set391504400E391504400E2016-09-16
00886333004218V•Stick™ Vascular Access Set391504500E391504500E2016-09-16
00886333004225V•Stick™ Vascular Access Set391505000E391505000E2016-09-16
00886333004232V•Stick™ Vascular Access Set391505300E391505300E2016-09-16
00886333004249V•Stick™ Vascular Access Set391505400E391505400E2016-09-16
00886333004256V•Stick™ Vascular Access Set391505500E391505500E2016-09-16
00886333004263V•Stick™ Vascular Access Set391605300E391605300E2016-09-16
00886333004270V•Stick™ Vascular Access Set391604000E391604000E2016-09-16
00886333004287V•Stick™ Vascular Access Set391604300E391604300E2016-09-16
00886333004294V•Stick™ Vascular Access Set391604400E391604400E2016-09-16
00886333004300V•Stick™ Vascular Access Set391604500E391604500E2016-09-16
00886333004317V•Stick™ Vascular Access Set391605000E391605000E2016-09-16
00886333004324V•Stick™ Vascular Access Set391605400E391605400E2016-09-16
00886333004331V•Stick™ Vascular Access Set391605500E391605500E2016-09-16
00886333007042V•Stick™ Vascular Access Set391705400E391705400E2016-09-16

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