FDA.reportPublic FDA data

SURFLO

Primary DI
34806017512256
Brand
SURFLO
Company
TERUMO (PHILIPPINES) CORPORATION
Model
SR-OX2032CA
Device description
SURFLO IV Catheter
Published
2016-09-14
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

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133280000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133280000TERUMO SURFLO I.V. CATHETERTerumo (Philippines) Corporation2014-06-12FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54806017512250PackageGS14In Commercial Distribution
74806017512254PackageGS110In Commercial Distribution
34806017512256PrimaryGS10
14806017512252Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5480601751225054806017512250
7480601751225474806017512254
3480601751225634806017512256
1480601751225214806017512252

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral intravenous cannulaA short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length1.25Inch

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.

Contacts#

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

Regulatory Flags#

DUNS number
718848773
Device count
50
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
34806017510146SURFLOSR-OX1451CA2016-09-14
34806017510153SURFLOSR-OX1632CA2016-09-14
34806017510160SURFLOSR-OX1651CA2016-09-14
34806017510177SURFLOSR-OX1664CA2016-09-14
34806017510184SURFLOSR-OX1851CA2016-09-14
34806017510191SURFLOSR-OX1864CA2016-09-14
34806017512225SURFLOSR-OX1464CA2016-09-14
34806017512232SURFLOSR-OX1832CA2016-09-14
34806017512249SURFLOSR-OX2051CA2016-09-14
34806017512263SURFLOSR-OX2025CA2016-09-14
34806017512270SURFLOSR-OX2225CA2016-09-14
34806017512287SURFLOSR-OX2419CA2016-09-14
14806017506992SURGUARD2SG2+18252017-02-06
14806017507005SURGUARD2SG2+18382017-02-28
14806017507012SURGUARD2SG2+19252017-02-28
14806017507029SURGUARD2SG2+19382017-02-28
14806017507036SURGUARD2SG2+20252017-02-28
14806017507043SURGUARD2SG2+20382017-02-28
14806017507050SURGUARD2SG2+21252017-02-28
14806017507067SURGUARD2SG2+21382017-02-28

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Primary DI, Brand, Company table
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10801902167344ARROWTELEFLEX INCORPORATEDFOZ2026-07-30
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10801902226379ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
10801902226386ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
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08032248007123SOL CARE T DELTA MED SPAFOZ2021-03-30
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