FDA.reportPublic FDA data

SampLok®

Primary DI
19555240400175
Brand
SampLok®
Company
ITL ASIA PACIFIC SDN. BHD.
Model
A100400
Catalog number
A100400
Device description
SampLok without Lid (TitanPro), TR Blue, Bulk, Non-Sterile; It is intended as a needle holder for a Luer adapter needle to vacuum blood collection tube.
Published
2019-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000777000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000777000SAMPLOKItl Corporation Pty, Ltd.2000-04-11JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19555240400175PrimaryGS10
09555240400178Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1955524040017519555240400175
09555240400178095552404001789555240400178

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection tube holder, single-useA hand-held cylindrical device designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
597723837
Device count
1000
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
19555240401431Safety SubCulture Unit 2 (SCU2)A100722A1007222020-09-19
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
19555240401219SampLok® Adapter Cap 2A100715A1007152019-03-29

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