FDA.reportPublic FDA data

SURFLO HYBRIA

Primary DI
36927675520549
Brand
SURFLO HYBRIA
Company
Terumo Medical Products (Hangzhou) Co., Ltd.
Model
SH20322320AF
Catalog number
SH20322320AF
Device description
SURFLO HYBRIA Closed I.V. Catheter
Published
2026-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K252398000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252398000SURFLO Hybria Closed System Safety IV CatheterTerumo Medical Products (Hangzhou) Co., Ltd.2025-12-17FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
56927675520543PackageGS14In Commercial Distribution
36927675520549PrimaryGS10
06927675520548Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5692767552054356927675520543
3692767552054936927675520549
06927675520548069276755205486927675520548

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
Catheter Gauge1French
Device Size Text, specify0
Device Size Text, specify0
Length32Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid exposure to water, direct sunlight, extreme temperature, or high humidity during storage.Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 8.

Contacts#

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

Regulatory Flags#

DUNS number
544830912
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
36927675520433SURFLO MIDELAMCSD001FMCSD001F2026-04-01
36927675517273SURFLO MIDELAMCS1810D01FMCS1810D01F2026-04-01
36927675517280SURFLO MIDELAMCS2010D00FMCS2010D00F2026-04-01
36927675517297SURFLO MIDELAMCS2208D01FMCS2208D01F2026-04-01
36927675517303SURFLO MIDELAMCS1810D00FMCS1810D00F2026-04-01
36927675517310SURFLO MIDELAMCS2208D00FMCS2208D00F2026-04-01
36927675519857SURFLO MIDELAMCS1808D00FMCS1808D00F2026-04-01
36927675519864SURFLO MIDELAMCS2008D00FMCS2008D00F2026-04-01
36927675520457SURFLO HYBRIASH18322332AFSH18322332AF2026-04-01
36927675520464SURFLO HYBRIASH18252332AFSH18252332AF2026-04-01
36927675520471SURFLO HYBRIASH20322332AFSH20322332AF2026-04-01
36927675520488SURFLO HYBRIASH20252332AFSH20252332AF2026-04-01
36927675520495SURFLO HYBRIASH22252332AFSH22252332AF2026-04-01
36927675520501SURFLO HYBRIASH22192332AFSH22192332AF2026-04-01
36927675520518SURFLO HYBRIASH24192332AFSH24192332AF2026-04-01
36927675520525SURFLO HYBRIASH18322320AFSH18322320AF2026-04-01
36927675520532SURFLO HYBRIASH18252320AFSH18252320AFF2026-04-01
36927675520556SURFLO HYBRIASH20252320AFSH20252320AF2026-04-01
36927675520563SURFLO HYBRIASH22252320AFSH22252320AF2026-04-01
36927675520570SURFLO HYBRIASH22192320AFSH22192320AF2026-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08032248007123SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007130SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007147SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007154SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007161SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007178SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007185SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007192SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007208SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007215SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007222SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007239SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007246SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007253SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007260SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007277SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007284SOL CARE 1 DELTA MED SPAFOZ2021-03-30
08032248007291SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248005372Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005389Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005396Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005402Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005419Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005426Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005433Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005440Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005457Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005464Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005471Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005495Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26