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
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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 IVD, no additiveA 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 Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
122561087
Device count
200
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30382902263068BD BBL™ Prompt™ Inoculation System2263062263062016-04-29
30382904203154BD SurePrep™ Capillary Tubes- PLAIN4203154203152018-05-25
30382904203161BD SurePrep™ Capillary Tubes- HEPARINIZED4203164203162018-05-25
30382904203178BD SurePrep™ Capillary Tubes- HEPARINIZED4203174203172018-05-25
30382904203185BD SurePrep™ Capillary Tubes- PRECALIBRATED4203184203182018-05-25
00885403530534Fogarty12TLW404F12TLW404F2026-08-14
00885403530541Fogarty12TLW803F12TLW803F2026-08-14
00885403530558Fogarty12TLW804F12TLW804F2026-08-14
00885403530572Fogarty12TLW806F12TLW806F2026-08-14
00885403530589FOGARTY12TLW807F12TLW807F2026-08-14
00382904411244BD ProbeTec™ (GC) Qx Amplified DNA Assay4411244411242016-07-07
00382902780519BD Macro-Vue™ Card Test Rotator2780512780512016-05-19
00885403522324Swan-Ganz151F7151F72026-07-31
00885403523581VAMP48VMP10648VMP1062026-07-31
00885403523598VAMP48VMP12048VMP1202026-07-31
00885403523734VAMP48VMP18448VMP1842026-07-31
00885403524281TruWave, VAMP PlusPXVP1087PXVP10872026-07-31
00885403524694TruWave, VAMP PlusPXVP0550PXVP05502026-07-31
00885403524922TruWavePX266CPX266C2026-07-31
00885403525066TruWave, VAMPPXAVMPPXAVMP2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850059420515SAFECAPDRUMMOND SCIENTIFIC COMPANYGIO2026-05-18
00850059420492MICROSAFEDRUMMOND SCIENTIFIC COMPANYGIO2026-04-17
00850059420508MICROSAFEDRUMMOND SCIENTIFIC COMPANYGIO2026-04-17
00857182006784UltraFlo-CInnovative Medical Technologies, Inc.GIO2025-12-30
00857182006807UltraFlo-CInnovative Medical Technologies, Inc.GIO2025-12-30
00848530108113DIATUBE002SUNSET HEALTHCARE SOLUTIONS, INC.GIO2025-12-23
10848530108110DIATUBE002SUNSET HEALTHCARE SOLUTIONS, INC.GIO2025-12-23
00381934774015PTS Diagnostics Capillary TubesPOLYMER TECHNOLOGY SYSTEMS, INC.GIO2025-06-16
10381934774012PTS Diagnostics Capillary TubesPOLYMER TECHNOLOGY SYSTEMS, INC.GIO2025-06-16
06974621793259LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
06974621793266LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
06974621793273LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
06974621793280LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
06974621793297LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
16974621793256LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
16974621793263LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
16974621793270LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
16974621793287LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
16974621793294LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
06974621793303LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
06974621793310LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
06974621793327LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
16974621793300LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
16974621793317LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
16974621793324LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
00860001024067MICROSAFEDRUMMOND SCIENTIFIC COMPANYGIO2025-05-06
00850059420423MICROSAFEDRUMMOND SCIENTIFIC COMPANYGIO2025-02-05
00850059420430MICROSAFEDRUMMOND SCIENTIFIC COMPANYGIO2025-02-05
00850059420447MICROSAFEDRUMMOND SCIENTIFIC COMPANYGIO2025-02-05
00850059420454MICROSAFEDRUMMOND SCIENTIFIC COMPANYGIO2025-02-05