FDA.reportPublic FDA data

LT Tube for PRP

Primary DI
16974621793096
Brand
LT Tube for PRP
Company
Zhuhai Longtime Biological Technology Co., Ltd
Model
30GT1
Published
2023-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GIOTube, Collection, Capillary Blood

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974621793096PackageGS11In Commercial Distribution
56974621793094PackageGS150In Commercial Distribution
06974621793099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697462179309616974621793096
5697462179309456974621793094
06974621793099069746217930996974621793099

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate systemAn assembly of devices typically used at the point-of-care to concentrate platelets or bone marrow aspirate cells, through low-speed centrifugal force (e.g., 2,500 to 7,000 rpm), from a small volume of a patient's own blood/bone marrow for the rapid preparation of platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC). It typically consists of a centrifuge, a dedicated centrifuge tube(s) and sample collection/processing kits, a concentrate delivery unit, and various disposable applicators. After processing, the concentrates are applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
708328288
Device count
1
DM exempt
false
Premarket exempt
true
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
06974621793006LT Kit for PRPPRP-B12023-06-05
06974621793037LT Kit for PRPPRP-B22023-06-05
06974621793204LT Medical Centrifuge for Blood Grouping CardLTA-12A 2023-06-05
06974621793211LT Medical Centrifuge for Blood Grouping CardLTA-24A 2023-06-05
06974621793259LT Kit for PRPPRP1012025-06-09
06974621793266LT Kit for PRPPRP1512025-06-09
06974621793273LT Kit for PRPPRP1522025-06-09
06974621793280LT Kit for PRPPRP2012025-06-09
06974621793297LT Kit for PRPPRP2022025-06-09
06974621793303LT Kit for PRPPRP2512025-06-06
06974621793310LT Kit for PRPPRP2522025-06-06
06974621793327LT Kit for PRPPRP3012025-06-06
06974621793334LT Tube for PRPPRP102025-06-06
06974621793341LT Tube for PRPPRP152025-06-06
06974621793358LT Tube for PRPPRP202025-06-06
06974621793365LT Tube for PRPPRP252025-06-06
06974621793372LT Tube for PRPPRP302025-06-06
06974621793129LT ABO_Rh (D) Blood Grouping CardBGC-62023-08-01
06974621793136LT ABO_Rh (D) Blood Grouping CardBGC-82023-08-01
06974621793143LT Blood Cross Matching CardBCM-62023-08-01

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
06974621793334LT Tube for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
06974621793341LT Tube for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
06974621793358LT Tube for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
06974621793365LT Tube for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
00860001024067MICROSAFEDRUMMOND SCIENTIFIC COMPANYGIO2025-05-06