FDA.reportPublic FDA data

Progen PRP Advantage

Primary DI
00850035498392
Brand
Progen PRP Advantage
Company
Bellus Medical, LLC
Model
TN15MLSINGLE
Catalog number
F5PG013.02
Device description
15 mL Blood Draw Kit - Single
Published
2022-05-09
Public version status
New
Distribution status
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
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
00850035498392PackageGS13In Commercial Distribution
00850035498378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850035498392008500354983928500354983920850035498392
00850035498378008500354983788500354983780850035498378

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888.372.3982customerservice@crownaesthetics.com

Regulatory Flags#

DUNS number
005677967
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850060751738SkinPenF5SP5812026-05-20
00850060751028SkinPen Precision EliteREF015F5SP3882024-10-01
00850060751110ProGen PRP EclipseP5PG052PROGEN-A152024-08-28
00850060751158ProGen PRP EclipseP5PG053PROGEN-A302024-08-28
00850035498279SP MicroPen EVO Microneedling CartridgeF5SP2232022-05-25
00863221000323SkinPen Precision Treatment KitF5SP013F5SP0132018-04-09
00850060751004SkinPen Precision EliteREF200F5SP386, F5SP4182024-10-01
00850060751011SkinPen Precision EliteREF201F5SP387, F5SP419, F5SP4542024-10-01
00850060751103ProGen PRP EclipseP5PG0192024-08-28
00850060751141ProGen PRP EclipseP5PG0202024-08-28
00850035498262SP MicroPen EVOF5SP2162022-05-25
00850035498378Progen PRP EclipseTN15MLSINGLEF5PG013.022022-05-09
00850035498385Progen PRP EclipseTN30MLSINGLEF5PG014.022022-05-09
00850060751035SkinPen Precision EliteREF200/REF201F5SP3892024-10-01
00850035498873SkinPen Precision Premium Treatment KitF5SP391F5SP3912023-07-31
00850035498415Progen PRP EclipseF5PG0172022-04-22
00850035498422Progen PRP EclipseF5PG0182022-04-22
00850035498439Progen PRP EclipseF5PG0192022-04-22
00850035498446Progen PRP EclipseF5PG0202022-04-22
10863221000320SkinPen Precision Treatment Kits1F5SP0182018-04-09

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