FDA.report

Leak Detection System

Primary DI
B297ACLD10000
Brand
Leak Detection System
Company
SPECIALITY WATER TECHNOLOGY
Model
A-C-LD-1000
Device description
Leak Detection System with audible alarm, call notification, manual reset
Published
2017-04-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FIPSubsystem, Water Purification

Product Code Classifications

CodeDeviceSpecialtyClass
FIPSubsystem, Water PurificationGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B297ACLD10000PrimaryHIBCC0

GMDN Terms

TermDefinition
Combination water purification systemAn assembly of electrically-powered devices, or stand-alone device, designed to remove unwanted chemical, particulate, and/or biological contaminants from water. This system purifies water using a combination of methods including particulate filtration, chemical disinfection, deionization, reverse osmosis, and/or ultraviolet light.

Sterilization Methods

Method

Contacts

PhoneEmail
615-654-4441sales@specialtyh2o.com

Regulatory Flags

DUNS number
032528935
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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