FDA.report

SURFLASH

Primary DI
54987350709702
Brand
SURFLASH
Company
TERUMO CORPORATION
Model
SR*FVP1832
Device description
SURFLASH Plus
Published
2016-09-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FOZCatheter,intravascular,therapeutic,short-term less than 30 days

Product Code Classifications

CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
54987350709702PackageGS14Not in Commercial Distribution
34987350709708PrimaryGS10
04987350709707Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
5498735070970254987350709702
3498735070970834987350709708
04987350709707049873507097074987350709707

GMDN Terms

TermDefinition
Peripheral vascular catheterA sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length1.25Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Do not store at extreme temperature and humidity.
Special Storage Condition, Specify00Stacking limit by 5, Keep away from sunlight, Fragile, handle with care, Keep dry

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)283-7866tmccustomer.admin@terumomedica

Regulatory Flags

DUNS number
690543319
Device count
50
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

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