FDA.reportPublic FDA data

Health Care Logistics, Inc®

Primary DI
10827989007694
Brand
Health Care Logistics, Inc®
Company
Health Care Logistics, Inc.
Model
19388
Device description
Enema Bottles and Tips, 2oz, PET
Published
2025-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCEEnema Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCEEnema KitGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827989007694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1082798900769410827989007694

GMDN Terms#

Term, Definition table
TermDefinition
Rectal irrigation kitA collection of devices that includes a rectal irrigation nozzle (also known as a catheter) intended to be used as part of a rectal irrigation system for the introduction of a non-medicated solution (typically water) into the rectum for patients affected by faecal incontinence or constipation; it is not intended for colostomy site irrigation or irrigation of the entire colon. In addition to the disposable nozzle, it includes a reusable fluid container (e.g., water bag). It is intended for use in the home and healthcare facility. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8008481633hcl@GoHCL.com

Regulatory Flags#

DUNS number
092159383
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
80827989007938Health Care Logistics, Inc®172852026-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501256ESMARCH'S MEDICAL MUGS SINGLE-USEASSOMEDIKA, OOOFCE2026-05-26
16971919462528Medi GradeNingbo Albert Novosino Co.,Ltd.FCE2025-12-29
00661392042483LSL HEALTHCARELSL Industries, LLCFCE2025-10-30
00661392011649LSL HEALTHCARELSL Industries, LLCFCE2025-05-16
10661392011646LSL HEALTHCARELSL Industries, LLCFCE2025-05-16
00661392000902LSL HEALTHCARELSL Industries, LLCFCE2025-05-15
10661392000909LSL HEALTHCARELSL Industries, LLCFCE2025-05-15
10827989007700Health Care Logistics, Inc®Health Care Logistics, Inc.FCE2025-03-13
10192253028997DoverCardinal Health 200, LLCFCE2025-01-16
10192253029017DoverCardinal Health 200, LLCFCE2025-01-16
50192253028995DoverCardinal Health 200, LLCFCE2025-01-16
50192253029015DoverCardinal Health 200, LLCFCE2025-01-16
07333387024769Navina™ Catheter Set ConeWellspect ABFCE2025-01-10
07333387052601Navina™ Classic System RefillWellspect ABFCE2025-01-10
07333387052625Navina™ Smart SystemWellspect ABFCE2025-01-10
07333387052564Navina™ Catheter Set ConeWellspect ABFCE2025-01-10
07333387052779Navina Mini Refill SetWellspect ABFCE2024-10-28
07333387052816Navina™ Mini SetWellspect ABFCE2024-10-28
07333387052830Navina Mini Extension SetWellspect ABFCE2024-10-28
07333387052878Navina™ Mini Start SetWellspect ABFCE2024-10-28
07333387052854Navina Mini Refill SetWellspect ABFCE2024-10-28
07333387052823Navina™ Mini SetWellspect ABFCE2024-10-28
07333387052847Navina Mini Extension SetWellspect ABFCE2024-10-28
07333387052885Navina™ Mini Start SetWellspect ABFCE2024-10-28
06971919461395PREMIUMNingbo Albert Novosino Co.,Ltd.FCE2024-03-11
06971919461401PREMIUMNingbo Albert Novosino Co.,Ltd.FCE2024-03-11
05055270979308RocketROCKET MEDICAL PLCFCE2023-10-24
05055270979322RocketROCKET MEDICAL PLCFCE2023-10-24
07333387029313Navina™ Classic System ConeWellspect ABFCE2023-09-25
07333387029702Navina™ Classic System Cone RefillWellspect ABFCE2023-09-25