FDA.reportPublic FDA data

FlowEase [Subcutaneous] Infusion Set

Primary DI
00642621029253
Brand
FlowEase [Subcutaneous] Infusion Set
Company
Baxalta US Inc.
Model
1M2012
Catalog number
1M2012
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
20642621029257PackageGS112In Commercial Distribution
50642621029258PackageGS18In Commercial Distribution
00642621029253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2064262102925720642621029257
5064262102925850642621029258
00642621029253006426210292536426210292530642621029253

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous infusion/injection port needleA sterile, sharp bevel-edged, hollow tubular metal instrument intended to be attached to a syringe and designed for the therapeutic injection or infusion of medicinal substances directly beneath the skin layer. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Millimeter
Needle Gauge24Gauge

Regulatory Flags#

DUNS number
079887619
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00642621029239FlowEase [Subcutaneous] Infusion Set1M20061M20062016-09-28
00642621029246FlowEase [Subcutaneous] Infusion Set1M20091M20092016-09-28
00642621029383BAXJECT II Hi-Flow NTD3406013406012016-09-28
00642621003949BAXJECT II NTD150583415058342016-09-28
50642621003944BAXJECT II NTD150583415058342016-09-28
50642621029234FlowEase [Subcutaneous] Infusion Set1M20061M20062016-09-28
50642621029241FlowEase [Subcutaneous] Infusion Set1M20091M20092016-09-28
50642621029258FlowEase [Subcutaneous] Infusion Set1M20121M20122016-09-28

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