FDA.report

EXEL Huber Infusion Set

Primary DI
30020221279482
Brand
EXEL Huber Infusion Set
Company
Exel International
Model
27948
Catalog number
27948
Device description
Huber Infusion Set, non-coring, right angle, 22G X 1, with Y injection site, rotating wing, 7"tube
Published
2016-09-23
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

Related Records

Product Codes

CodeName
FPASet, Administration, Intravascular

Product Code Classifications

CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20020221279485PackageGS12In Commercial Distribution
30020221279482PackageGS120In Commercial Distribution
10020221279488PrimaryGS10
00020221279481Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2002022127948520020221279485
3002022127948230020221279482
1002022127948810020221279488
00020221279481000202212794810202212794810020221279481

GMDN Terms

TermDefinition
Vascular port administration setA collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
180572216
Device count
25
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
true
Sterilization required before use
false

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