FDA.report

N/A

Primary DI
05030267044832
Brand
N/A
Company
Intersurgical Incorporated
Model
1790000
Device description
AIR-GUARD CLEAR BREATHING FILTER
Published
2020-11-15
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
true

Related Records

Contact Domains

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05030267044832PackageGS150In Commercial Distribution
05030267055067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05030267044832050302670448325030267044832
05030267055067050302670550675030267055067

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
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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