FDA.reportPublic FDA data

SURFLO

Primary DI
34987350726125
Brand
SURFLO
Company
TERUMO CORPORATION
Model
SV*18BLK
Device description
Surflo Winged Infusion Set
Published
2017-01-26
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
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54987350726129PackageGS110Not in Commercial Distribution
34987350726125PrimaryGS10
04987350726124Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5498735072612954987350726129
3498735072612534987350726125
04987350726124049873507261244987350726124

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
Total Volume0.46Milliliter

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
690543319
Device count
50
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987350722164Misago®SXR07040LSX*FXA0740LN2015-05-30
04987350722188Misago®SXR07060LSX*FXA0760LN2015-05-30
04987350722348Misago®SXR08100LSX*FXA08X0LN2015-05-30
04987350722089Misago®SXR06060LSX*FXA0660LN2015-05-30
04987350722102Misago®SXR06080LSX*FXA0680LN2015-05-30
04987350722126Misago®SXR06120LSX*FXA06X2LN2015-05-30
04987350722140Misago®SXR06150LSX*FXA06X5LN2015-05-30
04987350722201Misago®SXR07080LSX*FXA0780LN2015-05-30
04987350722225Misago®SXR07100LSX*FXA07X0LN2015-05-30
04987350722287Misago®SXR08040LSX*FXA0840LN2015-05-30
04987350722300Misago®SXR08060LSX*FXA0860LN2015-05-30
04987350722324Misago®SXR08080LSX*FXA0880LN2015-05-30
04987350722362Misago®SXR06100LSX*FXA06X0LN2015-05-30
04987350722065Misago®SXR06040LSX*FXA0640LN2015-05-30
04987350722249Misago®SXR07120LSX*FXA07X2LN2015-05-30
04987350722263Misago®SXR07150LSX*FXA07X5LN2015-05-30
04987350739124CAPIOXCX*FX05WACX*FX05WA2021-07-06
04987350739100CAPIOXCX*FX05EACX*FX05EA2021-07-01
04987350781710CAPIOX®FXCX*FX05E2015-09-15
04987350781734CAPIOX®FXCX*FX05W2015-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885403533822BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-23
00850017421585twiistSEQUEL MED TECH, LLCFPA2026-10-19
10885403520631BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
10885403533839BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
10885403533846BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
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