FDA.reportPublic FDA data

FlowEase [Subcutaneous] Infusion Set

Primary DI
50642621029241
Brand
FlowEase [Subcutaneous] Infusion Set
Company
BAXALTA US INC.
Model
1M2009
Catalog number
1M2009
Published
2016-09-28
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

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121092000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121092000FLOWEASE [SUBCUTANEOUS] INFUSION SETBaxter Healthcare Corp2012-06-29FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20642621029240PackageGS112In Commercial Distribution
50642621029241PackageGS18In Commercial Distribution
00642621029246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2064262102924020642621029240
5064262102924150642621029241
00642621029246006426210292466426210292460642621029246

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous injection/infusion port needleA sterile, sharp bevel-edged, hollow tubular metal instrument 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
Length9Millimeter
Needle Gauge24Gauge

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079887619
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00642621029239FlowEase [Subcutaneous] Infusion Set1M20061M20062016-09-28
00642621029246FlowEase [Subcutaneous] Infusion Set1M20091M20092016-09-28
00642621029253FlowEase [Subcutaneous] Infusion Set1M20121M20122016-09-28
00642621029383BAXJECT II Hi-Flow NTD3406013406012016-09-28
00642621003949BAXJECT II NTD150583415058342016-09-28
50642621003944BAXJECT II NTD150583415058342016-09-28
50642621029234FlowEase [Subcutaneous] Infusion Set1M20061M20062016-09-28
50642621029258FlowEase [Subcutaneous] Infusion Set1M20121M20122016-09-28

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