FDA.reportPublic FDA data

Marian Medical

Primary DI
00816339023166
Brand
Marian Medical
Company
ALL-MED INC
Model
ETT-B1551
Catalog number
ETT-B1551.13
Device description
"30"" General Purpose Extension Set with Male Luer Lock, and Female Luer Lock. Lipid Resistant, Non-DEHP PVC tubing, Latex Free. Approximate Priming Volume: 5.0ml"
Published
2025-03-28
Public version status
New
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
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816339023163PackageGS150In Commercial Distribution
00816339023166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081633902316310816339023163
00816339023166008163390231668163390231660816339023166

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
603-355-4843customerservice@allmedinc.com

Regulatory Flags#

DUNS number
012789116
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816339023159SS-1660SS-16602025-03-28
10816339020018All-Med, Inc.MC2406-SS2016-09-24
10816339020025All-Med, Inc.MC2409-SS2016-09-24
10816339020032All-Med, Inc.MC2412-SS2016-09-24
10816339020049All-Med, Inc.MC4206-SS2016-09-24
10816339020056All-Med, Inc.MC4209-SS2016-09-24
10816339020063All-Med, Inc.MC4212-SS2016-09-24
10816339020070All-Med, Inc.MC420624G-SS2016-09-24
10816339020087All-Med, Inc.MC420924G-SS2016-09-24
10816339020094All-Med, Inc.MC421224G-SS2016-09-24
10816339020100All-Med, Inc.MCBI2409-SS2016-09-24
10816339020117All-Med, Inc.MCBI2412-SS2016-09-24
10816339020124All-Med, Inc.MCBI3606-SS2016-09-24
10816339020131All-Med, Inc.MCBI3609-SS2016-09-24
10816339020148All-Med, Inc.MCBI3612-SS2016-09-24
10816339020155All-Med, Inc.MCBI360624G-SS2016-09-24
10816339020162All-Med, Inc.MCBI360924G-SS2016-09-24
10816339020179All-Med, Inc.MCBI361224G-SS2016-09-24
10816339020186All-Med, Inc.MCTI3606-SS2016-09-24
10816339020193All-Med, Inc.MCTI3609-SS2016-09-24

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