FDA.reportPublic FDA data

SURFLO

Primary DI
56927675515471
Brand
SURFLO
Company
Terumo Medical Products (Hangzhou) Co., Ltd.
Model
SV*25EL
Catalog number
SV*25EL
Device description
SURFLO Winged Infusion Set
Published
2023-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
K221411000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221411000Surflo Winged Infusion SetTerumo Medical Products (Hangzhou) Co., Ltd.2023-06-23FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
56927675515471PackageGS110In Commercial Distribution
36927675515477PrimaryGS10
06927675515476Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5692767551547156927675515471
3692767551547736927675515477
06927675515476069276755154766927675515476

GMDN Terms#

Term, Definition table
TermDefinition
Basic intravenous administration set, invasiveA collection of devices which includes a hypodermic needle (e.g., venous butterfly/scalp vein needle) intended to conduct fluids from an intravenous (IV) fluid container to a patient's venous system during administration; it may also be used for blood collection. In addition to the needle, the set may include tubing, connectors, chambers, clamps, gauze pads, alcohol pads and dressings; a bag/bottle may also be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length0.75Inch
Needle Gauge25Gauge
Total Volume0.3Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00" DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
544830912
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
true
Sterilization required before use
false

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
36927675520549SURFLO HYBRIASH20322320AFSH20322320AF2026-04-01
36927675520556SURFLO HYBRIASH20252320AFSH20252320AF2026-04-01
36927675520563SURFLO HYBRIASH22252320AFSH22252320AF2026-04-01

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07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
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