FDA.reportPublic FDA data

Health Care Logistics, Inc®

Primary DI
10827989007731
Brand
Health Care Logistics, Inc®
Company
Health Care Logistics, Inc.
Model
9515
Catalog number
9515
Device description
"Biohazard Stat Bag 6"" x 9"" 2mil thickness"
Published
2025-09-16
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NNIContainer, Specimen, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827989007731PrimaryGS10
00827989007734Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082798900773110827989007731
00827989007734008279890077348279890077340827989007734

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, no additive/mediumAn empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
8008481633hcl@GoHCL.com

Regulatory Flags#

DUNS number
092159383
Device count
100
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827989008090Health Care Logistics, Inc®74462026-06-09
00827989008076Health Care Logistics, Inc®DMP-BCSK2026-04-21
00827989008069Health Care Logistics, Inc®MOD-1299922026-04-13
00827989008021Health Care Logistics, Inc®MOD-1295722026-03-24
00827989008038Health Care Logistics, Inc®MOD-1295772026-03-24
00827989008045Health Care Logistics, Inc®MOD-1295802026-03-24
00827989008052Health Care Logistics, Inc®MOD-1295812026-03-24
00827989007857Health Care Logistics, Inc®213052026-03-13
00008279897857Health Care Logistics, Inc®213052026-01-29
00827989007970Chemo Vent31-50187232026-03-04
00827989007987Venting Needle31-20189552026-03-04
00827989007963Health Care Logistics, Inc®20337203372026-02-25
00827989007956Health Care Logistics, Inc®19934199342026-02-12
00827989007901Health Care Logistics, Inc®172822026-02-09
00827989007918Health Care Logistics, Inc®172832026-02-09
00827989007925Health Care Logistics, Inc®172842026-02-09
00827989007932Health Care Logistics, Inc®172852026-02-09
80827989007907Health Care Logistics, Inc®172822026-02-09
80827989007914Health Care Logistics, Inc®172832026-02-09
80827989007921Health Care Logistics, Inc®172842026-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827989008090Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2026-06-09
10809160522387HalyardAVID MEDICAL, INC.NNI2026-06-02
08800075627520OSUNG MNDOSUNG MND Co., Ltd.NNI2025-11-03
10840165500741StarCLICK 100Starplex Scientific Corp.NNI2025-10-10
10840165500765StarCLICK 100Starplex Scientific Corp.NNI2025-10-10
10840165500802LeakbusterStarplex Scientific Corp.NNI2025-10-10
10840165500567LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500581LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500604LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500628LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500642LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500680LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500703LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500208HistoplexStarplex Scientific Corp.NNI2025-05-30
10840165500086StarCLICK 100Starplex Scientific Corp.NNI2025-05-28
10840165500109LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500123LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500147LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500161LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500185HistoplexStarplex Scientific Corp.NNI2025-05-28
10840165500406LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500420LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165401185LeakbusterPretium Canada Packaging ULCNNI2025-04-29
10840165401406LeakbusterPretium Canada Packaging ULCNNI2025-04-29
00616784802138LabChoice Specimen Bags, Clear, 8" x 10"(20.3 cm x 25.4 cm) , 1.8 milDynarex CorporationNNI2025-04-07
00840117333420LabChoice Specimen Bags with Pouch, 4" x 6" (10.2 cm x 15.2 cm), 1.8 milDynarex CorporationNNI2025-04-07
19120126131452VACUETTEGreiner Bio-One GmbHNNI2025-04-02
00616784802039LabChoice Specimen Bags, 6" x 9" (15.2 cm x 22.9 cm), 1.8 mil, Non-SterileDynarex CorporationNNI2025-03-28
00840117333413LabChoice Specimen Bags, 12" x 15" (30.5 cm x 38.1 cm), 1.8 milDynarex CorporationNNI2025-03-28
10860009784892Ditek Urine Collection CupMedzah IndustriesNNI2025-03-06