FDA.reportPublic FDA data

DonorCare® Needle Guard Small Channel

Primary DI
19555240400137
Brand
DonorCare® Needle Guard Small Channel
Company
ITL ASIA PACIFIC SDN. BHD.
Model
A100100
Catalog number
A100100
Device description
DonorCare Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.
Published
2020-09-20
Public version status
New
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
KSSSupplies, Blood-Bank

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSSSupplies, Blood-BankHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK9800080

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK9800080

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19555240400137PrimaryGS10
09555240400130Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1955524040013719555240400137
09555240400130095552404001309555240400130

GMDN Terms#

Term, Definition table
TermDefinition
Needle guardA cap/cover intended to be extended over a used needle (attached to a syringe/autoinjector or not) to prevent accidental needle sticks, typically during removal of the needle. It is typically a plastic housing with appropriate shielding to prevent injury upon application, and is typically disposed of with the needle; it is not the needle cap provided with the needle. 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

Contacts#

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

Regulatory Flags#

DUNS number
597723837
Device count
1000
Lot or batch
true
Expiration date on label
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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Primary DI, Brand, Company table
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