FDA.reportPublic FDA data

SURFLASH

Primary DI
54987350747834
Brand
SURFLASH
Company
TERUMO CORPORATION
Model
SR*FF1664
Device description
SURFLASH I.V. catheter
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54987350747834PackageGS14In Commercial Distribution
34987350747830PrimaryGS10
04987350747839Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5498735074783454987350747834
3498735074783034987350747830
04987350747839049873507478394987350747839

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length2.5Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store at extreme temperature and humidity.
Special Storage Condition, Specify00Fragile, handle with care, Keep dry, Keep away from sunlight, Stacking limit by 8
Special Storage Condition, Specify00This way up, Fragile, Handle with care, Keep dry, Keep away from heat

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)283-7866tmccustomer.admin@terumomedica
+1(800)283-7866tmccustomer.admin@terumomedical.com

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987350740601GLIDEWIRE GT-RGT*GW1618AGT*GW1618A2026-02-06
04987350740625GLIDEWIRE GT-RGT*GA1818AGT*GA1818A2026-02-06
04987350740649GLIDEWIRE GT-RGT*GA1822AGT*GA1822A2026-02-06
54987350740668GLIDEWIRE GT-RGT*GE1818AGT*GE1818A2026-02-06
04987350740687GLIDEWIRE GT-RGT*GE1822AGT*GE1822A2026-02-06
54987350740699GLIDEWIRE GT-RGT*GW1818AGT*GW1818A2026-02-06
04987350740700GLIDEWIRE GT-RGT*GW1822AGT*GW1822A2026-02-06
04987350745422GLIDEWIRE GT-RGT*GW1622AGT*GW1622A2026-02-06
04987350744487DUALVIEWTU-DSS01CTU*DV01U2026-01-21
54953170465050VISIGLIDEG-240-2527AN36222312025-07-14
54953170465067VISIGLIDEG-240-2545AN36224312025-07-14
54953170465074VISIGLIDEG-240-3527AN36226312025-07-14
54953170465081VISIGLIDEG-240-3545AN36228312025-07-14
54953170465098VISIGLIDEG-240-2527SN36221312025-07-14
54953170465104VISIGLIDEG-240-2545SN36223312025-07-14
54953170465111VISIGLIDEG-240-3527SN36225312025-07-14
54953170465128VISIGLIDEG-240-3545SN36227312025-07-14
54953170465135VISIGLIDE2G-260-2527AN53677312025-07-14
54953170465142VISIGLIDE2G-260-2545AN53681312025-07-14
54953170465159VISIGLIDE2G-260-3527AN53679312025-07-14

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