FDA.reportPublic FDA data

Safety SubCulture Unit 2 (SCU2)

Primary DI
19555240401431
Brand
Safety SubCulture Unit 2 (SCU2)
Company
ITL ASIA PACIFIC SDN. BHD.
Model
A100722
Catalog number
A100722
Device description
SCU2 is a needleless device used to obtain samples from blood culture bottles and to prevent the risk of a potential needlestick injury.
Published
2020-09-19
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
LIBDevice, General Purpose, Microbiology, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIBDevice, General Purpose, Microbiology, DiagnosticMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19555240401448PackageGS148In Commercial Distribution
19555240401455PackageGS16In Commercial Distribution
19555240401431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1955524040144819555240401448
1955524040145519555240401455
1955524040143119555240401431

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Direct Sunlight
Special Storage Condition, Specify00Keep Dry

Contacts#

Phone, Email table
PhoneEmail
+18884112851sales@itlbiomedical.com

Regulatory Flags#

DUNS number
597723837
Device count
1
Premarket exempt
true
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
19555240400175SampLok®A100400A1004002019-03-29
09555240406361Cell Culture Sampler Wide Cap 2mLA100780A1007802026-06-23
09555240404992SCU Narrow Cap SamplerA100724A1007242025-06-04
09555240405616SampLok® Sampling Kit 16mLA100756A1007562025-06-04
19555240404999SCU Narrow Cap SamplerA100724A1007242025-06-04
19555240405613SampLok® Sampling Kit 16mLA100756A1007562025-06-04
09555240400536SampLok® Sampling Kit 16mLA100740A1007402019-03-29
09555240400734SampLok® Sampling Kit 10mLA100750A1007502019-03-29
09555240403865SampLok® Sampling Kit 35mLA100752A1007522019-08-21
09555240404084SampLok® Sampling Kit 20mLA100754A1007542020-02-29
09555240405593SCU Narrow Cap Sampler Syringe KitA100727A1007272025-04-21
19555240401110Safety SubCulture Unit (SCU)A100720A1007202020-09-19
19555240401400Transfer Cap SetA100730A1007302020-02-29
09555240404985SCU Wide Cap SamplerA100723A1007232024-12-11
19555240405590SCU Narrow Cap Sampler Syringe KitA100727A1007272025-04-21
09555240401304SampLok® Adapter Cap 2A100718A1007182019-03-29
09555240401540SampLok® Adapter Cap 3A100762A1007622019-03-29
09555240401557SampLok® Adapter Cap 3 InsertA100763A1007632019-03-29
19555240400014SampLok® Adapter Cap InsertA100709A1007092019-03-29
19555240401080ITL Essentials™ Needle Mat (Sterile)A500101A5001012020-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30197344074369MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
30197344074376MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
30197344074383MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
30197344074390MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
20197344074362MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
20197344074379MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
20197344074386MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
20197344074393MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
06973267011369RIGID INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0102TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267011376FLEXIBLE INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0103TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267012366RIGID INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0202TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267012373FLEXIBLE INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0203TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267013349RIGID INOCULATION NEEDLE,TUBE PACK,TYPENEX,LP0302TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267011345RIGID INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0102TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267011352FLEXIBLE INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0103TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267012342RIGID INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0202TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267012359FLEXIBLE INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0203TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267013332RIGID INOCULATION NEEDLE,TUBE PACK,TYPENEX,LP0302TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
05032384127993REAGENT SPOT INDOLE DMACAOXOID LIMITEDLIB2025-06-27
09555240404992SCU Narrow Cap SamplerITL ASIA PACIFIC SDN. BHD.LIB2025-06-04
19555240404999SCU Narrow Cap SamplerITL ASIA PACIFIC SDN. BHD.LIB2025-06-04
09555240405593SCU Narrow Cap Sampler Syringe KitITL ASIA PACIFIC SDN. BHD.LIB2025-04-21
19555240405590SCU Narrow Cap Sampler Syringe KitITL ASIA PACIFIC SDN. BHD.LIB2025-04-21
06973267011260Inoculating Loop 1ul rigid perforated bag pack Typenex, LP0102PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267011277Inoculating Loop 1ul flexible perforated bag packTypenex LP0103PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267012267Inoculating Loop 10ul rigid perforated bag packTypenex LP0202PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267012274Inoculating Loop 10ul flexible Typenex LP0203PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267013240Inoculating Needle Rigid perforated bag packTypenex LP0302PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267011246Inoculating Loop 1ul rigid perforated bag pack Typenex, LP0102PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267011253Inoculating Loop 1ul flexible perforated bag packTypenex LP0103PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13