FDA.reportPublic FDA data

SURFLO

Primary DI
34987350726149
Brand
SURFLO
Company
TERUMO CORPORATION
Model
SV*19BLK
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
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
54987350726143PackageGS110Not in Commercial Distribution
34987350726149PrimaryGS10
04987350726148Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5498735072614354987350726143
3498735072614934987350726149
04987350726148049873507261484987350726148

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
04987350700025OPTITORQUE40-5011RH*5TIG110A2016-09-09
04987350700049OPTITORQUE40-5012RH*5TIG210A2016-09-09
04987350700063OPTITORQUE40-5021RH*5BL3520A2016-09-09
04987350700087OPTITORQUE40-5022RH*5BL4020A2016-09-09
04987350700100OPTITORQUE40-5030RH*5SP0061A2016-09-09
04987350700124OPTITORQUE40-5031RH*5AP5561A2016-09-09
04987350700148OPTITORQUE40-5040RH*5SL3500A2016-09-09
04987350700162OPTITORQUE40-5041RH*5SL4000A2016-09-09
04987350700186OPTITORQUE40-5042RH*5SL5000A2016-09-09
04987350700209OPTITORQUE40-5043RH*5JR3500A2016-09-09
04987350700223OPTITORQUE40-5044RH*5JR4000A2016-09-09
04987350700247OPTITORQUE40-5045RH*5JR5000A2016-09-09
04987350700261OPTITORQUE40-5050RH*5BPIR00A2016-09-09
04987350700285OPTITORQUE40-5060RH*5SAL100A2016-09-09
04987350700308OPTITORQUE40-5061RH*5SAL200A2016-09-09
04987350700322OPTITORQUE40-6011RH*6TIG110A2016-09-09
04987350700346OPTITORQUE40-6012RH*6TIG210A2016-09-09
04987350700360OPTITORQUE40-6021RH*6BL3520A2016-09-09
04987350700384OPTITORQUE40-6022RH*6BL4020A2016-09-09
04987350700407OPTITORQUE40-6030RH*6SP0061A2016-09-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840009338VYGONVygon CorporationFPA2020-04-21
08498840009895VYGONVygon CorporationFPA2020-04-21
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423762Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423779Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423786Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423793Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423885Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423915Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423922Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423939Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423960Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423977Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917424004Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30