FDA.reportPublic FDA data

SURSHIELD

Primary DI
36927675503924
Brand
SURSHIELD
Company
Terumo Medical Products (Hangzhou) Co., Ltd.
Model
MN*SVS21B18
Catalog number
MN*SVS21B18
Device description
SURSHIELD Safety Winged Blood Collection Set
Published
2016-09-12
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
56927675503928PackageGS110In Commercial Distribution
36927675503924PrimaryGS10
06927675503923Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5692767550392856927675503928
3692767550392436927675503924
06927675503923069276755039236927675503923

GMDN Terms#

Term, Definition table
TermDefinition
Luer-ended blood collection tube spikeA device intended to be used during patient blood collection to facilitate transfer of a clinical blood specimen from blood collection tubing or a needle to a blood specimen receptacle (e.g., evacuated blood collection tube, adapted syringe). It is designed to be fitted to a blood collection tube holder, where it connects to the tubing or needle via a Luer connection at one end, and penetrates an evacuated blood collection tube at the other end for blood collection. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length0.75Inch
Needle Gauge21Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store at extreme temperature 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
Expiration 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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07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
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