FDA.reportPublic FDA data

SURFLO

Primary DI
54987350761014
Brand
SURFLO
Company
TERUMO CORPORATION
Model
SV*27EL
Device description
Surflo Winged Infusion Set
Published
2016-09-09
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54987350761014PackageGS110In Commercial Distribution
34987350761010PrimaryGS10
04987350761019Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5498735076101454987350761014
3498735076101034987350761010
04987350761019049873507610194987350761019

GMDN Terms#

Term, Definition table
TermDefinition
Scalp vein intravenous administration setA collection of sterile devices designed to conduct fluids from an intravenous (IV) fluid container into a patient's scalp vein. It typically includes tubing, connectors, chambers, clamps, and specialized needles to access scalp veins. The device is normally intended for use on paediatric patients, especially infants. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length0.5Inch
Total Volume0.29Milliliter

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

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
100
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
04987350739124CAPIOXCX*FX05WACX*FX05WA2021-07-06
04987350739100CAPIOXCX*FX05EACX*FX05EA2021-07-01
04987350781710CAPIOX®FXCX*FX05E2015-09-15
04987350781734CAPIOX®FXCX*FX05W2015-09-15
04987350383075HEARTRAIL40-6370GC-U6IL350N2016-09-09
04987350383099HEARTRAIL40-6371GC-U6IL350A2016-09-09
04987350383112HEARTRAIL40-6372GC-U6IL3G0N2016-09-09
04987350383136HEARTRAIL40-6373GC-U6IL400N2016-09-09
04987350383150HEARTRAIL40-6374GC-U6IL400A2016-09-09
04987350383174HEARTRAIL40-6375GC-U6IL450N2016-09-09
04987350383198HEARTRAIL40-6376GC-U6IL450A2016-09-09
04987350383235HEARTRAIL40-6380GC-U6IR100N2016-09-09
04987350383259HEARTRAIL40-6381GC-U6IR150N2016-09-09
04987350383273HEARTRAIL40-6382GC-U6IR200N2016-09-09
04987350423795HEARTRAIL40-6383GC-U6IR100A2016-09-09
04987350423818HEARTRAIL40-6385GC-U6IR200A2016-09-09
04987350423832HEARTRAIL40-6377GC-U6IL3G0A2016-09-09
04987350423856HEARTRAIL40-6384GC-U6IR150A2016-09-09
04987350423870HEARTRAIL40-6311GC-U6TG400N2016-09-09
04987350703163FINECROSS35-1430NC*F863A2016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
01081633602518WUSA6010NEOCHILD, LLCFPA2026-10-08
10612479285993McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
10612479286013McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
04046955765164IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-27
00884450707104Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
00884450707111Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
04046955114559IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-19
10850083986008TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986015TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986022TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986039TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10813153027339CodanCodan US CorporationFPA2026-07-31
10813153028312CodanCodan US CorporationFPA2026-07-31
10850048235196HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
10813153028329CodanCodan US CorporationFPA2026-07-17
00827989008243MedSafetyHealth Care Logistics, Inc.FPA2026-07-10
00840117349841IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm)Dynarex CorporationFPA2026-06-30
05051684018473LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018480LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23