FDA.reportPublic FDA data

SURFLO

Primary DI
36927675516351
Brand
SURFLO
Company
Terumo Medical Products (Hangzhou) Co., Ltd.
Model
SV27ELF
Catalog number
SV27ELF
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
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
56927675516355PackageGS110In Commercial Distribution
36927675516351PrimaryGS10
06927675516350Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5692767551635556927675516355
3692767551635136927675516351
06927675516350069276755163506927675516350

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 Gauge27Gauge
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."""

Contacts#

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

Regulatory Flags#

DUNS number
544830912
Device count
50
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
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
36927675520549SURFLO HYBRIASH20322320AFSH20322320AF2026-04-01
36927675520556SURFLO HYBRIASH20252320AFSH20252320AF2026-04-01
36927675520563SURFLO HYBRIASH22252320AFSH22252320AF2026-04-01

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07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
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07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
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08498840009338VYGONVygon CorporationFPA2020-04-21
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