FDA.report

DAR

Primary DI
10884522012294
Brand
DAR
Company
Covidien LP
Model
352/5855
Device description
Adult-Pediatric Electrostatic Filter HME with Catheter Mount,Small
Published
2021-01-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
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
10884522012294PackageGS125In Commercial Distribution
10884522028103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088452201229410884522012294
1088452202810310884522028103

GMDN Terms

TermDefinition
Heat/moisture exchanger insertable filterA dedicated membrane that is inserted into a reusable heat & moisture exchanger (HME) to capture a patient's exhaled heat and moisture, so that they can be used to heat and humidify therapeutic gases inspired by the patient typically during anaesthesia or intensive care ventilation. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Fragile, Keep dry, This side up

Sterilization Methods

Method

Contacts

PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags

DUNS number
058614483
Device count
1
DM exempt
false
Premarket exempt
false
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

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20884521841878Shiley80FXLTIN2026-03-16

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