FDA.reportPublic FDA data

All-Med, Inc.

Primary DI
10816339027208
Brand
All-Med, Inc.
Company
ALL-MED INC
Model
MCTI360624G-SS
Device description
24ga, 6mm, 36" Trifurcated Safety Subcutaneous Tissue Infusion Set with Transparent dressing, Latex Free, Non-DEHP PVC tubing, Priming Volume Approx.: .65ml
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10816339027208PackageGS110In Commercial Distribution
10816339020216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081633902720810816339027208
1081633902021610816339020216

GMDN Terms#

Term, Definition table
TermDefinition
Electronic gravity infusion controller administration setA collection of devices designed for the intravenous (IV) administration of fluid from a container, through an automated infusion controller, to a catheter/needle hub or extension tube set at the patient site. The collection typically consists of plastic tubing, a check valve, a roller clamp, a Y-piece connector for secondary tubing attachment, and Luer connectors at both ends. 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816339023159SS-1660SS-16602025-03-28
00816339023166Marian MedicalETT-B1551ETT-B1551.132025-03-28
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

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