FDA.reportPublic FDA data

BD Vacutainer® Rapid Serum Tube (RST) Blood Collection Tubes Thrombin

Primary DI
30382903687740
Brand
BD Vacutainer® Rapid Serum Tube (RST) Blood Collection Tubes Thrombin
Company
BECTON, DICKINSON AND COMPANY
Model
368774
Catalog number
368774
Device description
TUBE BD VACUTAINER RST 13X100 5.0ML
Published
2016-07-28
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

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
K101502000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101502000BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774Becton, Dickinson & CO2010-06-29JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903687744PackageGS110In Commercial Distribution
30382903687740PrimaryGS10
00382903687749Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290368774450382903687744
3038290368774030382903687740
00382903687749003829036877493829036877490382903687749

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, clot promoter/clot activator/separatorA glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, a blood clot activator, a blood clot promoter (e.g., thrombin), and a separator (e.g., gel or elastomer) to separate blood serum from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001292192
Device count
100
Lot or batch
true
Expiration date on label
true

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00885403530442Fogarty120804F120804F2026-07-31
00885403530466Fogarty120805F120805F2026-07-31
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