FDA.reportPublic FDA data

BD SurePrep™ Capillary Tubes- PLAIN

Primary DI
30382904203147
Brand
BD SurePrep™ Capillary Tubes- PLAIN
Company
BECTON, DICKINSON AND COMPANY
Model
420314
Catalog number
420314
Device description
BD SurePrep™ Capillary Tubes- PLAIN
Published
2018-05-25
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
GIOTUBE, COLLECTION, CAPILLARY BLOOD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIOTube, Collection, Capillary BloodHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K884623000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K884623000SAFE-TEC CAPILLARY BLOOD COLLECTION TUBESafe-Tec Clinical Products, Inc.1988-12-01GIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904203147PrimaryGS10
00382904203146Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290420314730382904203147
00382904203146003829042031463829042031460382904203146

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection tube, no additiveA non-sterile glass or plastic collection tube containing no additive, intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin). It is typically sealed at one or both ends with a putty-like substance following specimen collection, This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
Device count
200
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
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