FDA.report

Health Care Logistics, Inc®

Primary DI
80827989007846
Company
Health Care Logistics, Inc.
Model
21304
Device description
ENFit Bottle Adapter 12-15mm
Published
2026-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Regulatory Flags

DUNS number
092159383
Device count
100
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00827989007840PrimaryGS10
80827989007846Unit of UseGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00827989007840PrimaryGS10
80827989007846Unit of UseGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
KYXDispenser, Liquid Medication1General Hospital880.6430NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Medicine bottle capA sturdy covering designed to close off and seal the top of a medicine bottle providing protection from the external environment. It will typically consist of a plastic cover that may include a glued or cemented liner/seal, e.g., rubber or plastic. Some devices are threaded for screwing on to the bottle. Medicine bottle caps are frequently made with a built-in safety feature locking mechanism making them child proof, e.g., require a push-down/screw action to open. This device is reusable until the contents of the bottle are exhausted.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00827989007970Chemo Vent31-50187232026-03-04
00827989007987Venting Needle31-20189552026-03-04
00827989007963Health Care Logistics, Inc®20337203372026-02-25
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
00827989007949Health Care Logistics, Inc®MOD-1286112026-02-09
80827989007853Health Care Logistics, Inc®213052026-01-29
80827989007860Health Care Logistics, Inc®213062026-01-29
80827989007877Health Care Logistics, Inc®213072026-01-29
80827989007884Health Care Logistics, Inc®213082026-01-29
80827989007891Health Care Logistics, Inc®SPL-1284362026-01-29
80827989007778Health Care Logistics, Inc®20427204272025-12-19
80827989007792Health Care Logistics, Inc®20428204282025-12-19
00827989007826Suregrip21292212922025-12-19
00827989007833Suregrip21293212932025-12-19
10827989007618Health Care Logistics, Inc®21189C-312025-04-16
00827989007802Health Care Logistics, Inc®212942025-12-03
00827989007819Health Care Logistics, Inc®212952025-12-03

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00813360023639DoselogixTEAM TECHNOLOGIES, INC.KYX2026-03-24
80827989007853Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
80827989007860Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
80827989007877Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
80827989007884Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
80827989007891Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
00810126506351Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506368Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506375Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506382Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506399Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506405Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506412Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506429Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506436Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506443Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506450Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00194346098088EquateWAL-MART STORES, INC.KYX2025-11-14
04046955861132Exadoral®B. BRAUN MEDICAL INC.KYX2025-09-08
04046955861170Exadoral®B. BRAUN MEDICAL INC.KYX2025-09-08
04046955861217Exadoral®B. BRAUN MEDICAL INC.KYX2025-09-08
10810080612492OptiDropper®, SafeFill™MPS Pharma & Medical, Inc.KYX2025-08-19
10810080612485OptiDropper®MPS Pharma & Medical, Inc.KYX2025-08-15
00813360023189DoselogixTEAM TECHNOLOGIES, INC.KYX2025-08-01
00813360023196DoselogixTEAM TECHNOLOGIES, INC.KYX2025-08-01
00813360023202DoselogixTEAM TECHNOLOGIES, INC.KYX2025-08-01
00813360023219DoselogixTEAM TECHNOLOGIES, INC.KYX2025-08-01
10810080612461OptiDropper®MPS Pharma & Medical, Inc.KYX2025-07-19
00813360023240DoselogixTEAM TECHNOLOGIES, INC.KYX2025-06-05
00813360023257DoselogixTEAM TECHNOLOGIES, INC.KYX2025-06-05