FDA.report

Airsep Newlife, Newlife Elite Style Felt Filters

Primary DI
00848530050795
Brand
Airsep Newlife, Newlife Elite Style Felt Filters
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
OF8001
Catalog number
OF8001
Device description
Airsep Newlife, Newlife Elite Style Felt Filters (10/pack)
Published
2018-07-31
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
false

Related Records

Contact Domains

Product Codes

CodeName
JRLUnit, Filter, Membrane

Product Code Classifications

CodeDeviceSpecialtyClass
JRLUnit, Filter, MembraneClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848530050795PrimaryGS10
10848530050792Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530050795008485300507958485300507950848530050795
1084853005079210848530050792

GMDN Terms

TermDefinition
Anaesthesia conduction filterA sterile microporous membrane used to minimize particulate (foreign material) contamination of a local anaesthetic during administration to a patient (e.g., through an anaesthesia conduction catheter). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
877-578-6738customerservice@sunsethcs.com

Regulatory Flags

DUNS number
141668116
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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

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