FDA.reportPublic FDA data

Blood Collection Kit

Primary DI
00850037506170
Brand
Blood Collection Kit
Company
VERICEL CORPORATION
Model
N/A
Device description
The Blood Collection Kit is intended to provide a way to collect and transport venous blood samples to a biobanking facility. The Blood Collection Kit contains blood specimen collection devices and associated materials necessary to transport the samples to a biobanking facility. This includes two BD 10.0mL K2 EDTA (K2E) Plus Blood Collection Tubes (366643) and one VonSeal® 95kPA Biohazard Specimen Bag.
Published
2022-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)Clinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850037506170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850037506170008500375061708500375061700850037506170

GMDN Terms#

Term, Definition table
TermDefinition
Specimen container mailer, non-insulatedA non-sterile tube, box, or envelope designed to transport a specimen container/receptacle by mail and to provide protection for the container and its specimen content. It can be used for mail services internal or external to healthcare facilities and is intended to protect the specimen container (e.g., glass vial, bottle, tube, or slide) from adverse conditions that could cause breakage. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079745570
Device count
1
Premarket exempt
true
Kit
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850037506132MACI Surgical Implantation KitN/A2022-11-09
00850037506101Cutting Block890542022-11-09
00850037506057MACI Arthroscopic Instruments82024N/A2024-09-18
00850037506224MACI Arthroscopic Instruments82034N/A2024-09-18
00850037506262MACI Arthroscopic Instruments82038N/A2024-09-18
00850037506002MACI Arthroscopic Instruments82032N/A2024-08-26
00850037506019MACI Arthroscopic Instruments82023N/A2024-08-26
00850037506026MACI Arthroscopic Instruments82021N/A2024-08-26
00850037506033MACI Arthroscopic Instruments82020N/A2024-08-26
00850037506040MACI Arthroscopic Instruments82022N/A2024-08-26
00850037506064MACI Arthroscopic Instruments82026N/A2024-08-26
00850037506088MACI Arthroscopic Instruments82016N/A2024-08-26
00850037506217MACI Arthroscopic Instruments82033N/A2024-08-26
00850037506231MACI Arthroscopic Instruments82035N/A2024-08-26
00850037506248MACI Arthroscopic Instruments82036N/A2024-08-26
00850037506255MACI Arthroscopic Instruments82037N/A2024-08-26
00850037506279MACI Arthroscopic Instruments89060N/A2024-08-26
00860004093022MACI Arthroscopic Instruments82017N/A2024-08-26
00860004093039MACI Arthroscopic Instruments82018N/A2024-08-26
00860004093046MACI Arthroscopic Instruments82025N/A2024-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220803BASELINE Venous Sample Collection kitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
00850024881860LetsGetChecked Blood Sample Collection Kit (BIOM2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-05-06
00810010895011Aero-MedAERO-MED, LLCPQD2026-05-04
00810010894991Aero-MedAERO-MED, LLCPQD2026-04-07
00810010895004Aero-MedAERO-MED, LLCPQD2026-04-07
10885380211225Aero-MedAERO-MED, LLCPQD2026-03-20
50885380211223Aero-MedAERO-MED, LLCPQD2026-03-20
00850070635158KIT, BLOOD CULTURE COLLECTINGNar Medical Depot, LLCPQD2026-03-19
00810010894885Aero-MedAERO-MED, LLCPQD2026-03-17
50810010894880Aero-MedAERO-MED, LLCPQD2026-03-17
00810010894960Aero-MedAERO-MED, LLCPQD2026-03-17
00850066710272Simple HealthKitSIMPLE HEALTHKIT, INC.PQD2026-01-21
04779054721198RDA SpotRDA SPOT, UABPQD2026-01-15
00850015884351easycareSynchronis Medical, LLCPQD2026-01-07
00850015884368easycareSynchronis Medical, LLCPQD2026-01-07
04779054721129RDA SpotRDA SPOT, UABPQD2025-11-20
04779054721143RDA SpotRDA SPOT, UABPQD2025-11-20
04779054721082BLOODORDA SPOT, UABPQD2025-10-16
04779054721105BLOODORDA SPOT, UABPQD2025-10-16
04779054721112BLOODORDA SPOT, UABPQD2025-10-16
04779054721099BLOODORDA SPOT, UABPQD2025-10-13
04779054720276ZinzinoRDA SPOT, UABPQD2025-10-03
04779054720184ZinzinoRDA SPOT, UABPQD2025-09-16
04779054721013ZinzinoRDA SPOT, UABPQD2025-07-24
00810111410045LetsGetChecked Blood Sample Collection Kit (LIPP2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2025-07-07
00810111410281LetsGetChecked Blood Sample Collection Kit (PRGS)PRIVAPATH DIAGNOSTICS LIMITEDPQD2025-07-07