FDA.reportPublic FDA data

Millennium

Primary DI
00190776376154
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-CH03042201
Device description
Syringe Rug with Luer Lock Adaptor and Hypo Routing Needle
Published
2023-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FKCCLAMP, CANNULA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKCClamp, CannulaGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776376154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776376154001907763761541907763761540190776376154

GMDN Terms#

Term, Definition table
TermDefinition
Body aspiration needle, reusableA sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776397050Millennium85-160P208832026-07-16
00190776397067Millennium85-530366172026-07-16
00190776397074Millennium85-720391422026-07-16
00190776397081Millennium14-50052026-07-16
00190776397104Millennium85-770498932026-07-16
00190776397111Millennium85-230675902026-07-16
00190776397128Millennium85-640041212026-07-16
00190776397135Millennium85-710186192026-07-16
00190776397142Millennium85-300243682026-07-16
00190776397159Millennium85-780096162026-07-16
00190776397166Millennium85-900102152026-07-16
00190776397173Millennium85-520023162026-07-16
00190776397180Millennium85-528137762026-07-16
00190776397197Millennium85-520111272026-07-16
00190776397463Millennium85-140308682026-07-16
00190776398484Millennium85-800001202026-07-16
00190776398651Millennium85-590P015832026-07-16
00190776398668Millennium85-710378692026-07-16
00190776398682Millennium85-710369342026-07-16
00190776398699Millennium85-710374012026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840277128058Innomed, Inc.INNOMED, INC.FKC2022-01-10
00190776190088MillenniumAvalign Technologies, Inc.FKC2021-11-02
00190776190095MillenniumAvalign Technologies, Inc.FKC2021-11-02
00840277114549Innomed, Inc.INNOMED, INC.FKC2020-09-29
00840277115959Innomed, Inc.INNOMED, INC.FKC2020-09-29
00840277120786Innomed, Inc.INNOMED, INC.FKC2020-09-29
00840277124937Innomed, Inc.INNOMED, INC.FKC2020-09-29
10852250006083Lifemed Cannula ClampLIFEMED OF CALIFORNIAFKC2015-10-13