FDA.report

HYDRO-GUARD MINI BREATHING FILTER

Primary DI
05030267159079
Brand
HYDRO-GUARD MINI BREATHING FILTER
Company
INTERSURGICAL INCORPORATED
Model
1745801
Device description
HYDRO-GUARD MINI BREATHING FILTER
Published
2021-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CAHFilter, Bacterial, Breathing-Circuit

Product Code Classifications

CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05030267159079PackageGS1250In Commercial Distribution
05030267161249PackageGS150In Commercial Distribution
05030267159062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05030267159079050302671590795030267159079
05030267161249050302671612495030267161249
05030267159062050302671590625030267159062

GMDN Terms

TermDefinition
Microbial medical gas filter, single-useA screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy; it has no additional non-filtering functions. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
3154512900support@intersurgicalinc.com

Regulatory Flags

DUNS number
785952607
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
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
true
Sterilization required before use
false

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