FDA.reportPublic FDA data

DAR

Primary DI
30884522012359
Brand
DAR
Company
Covidien LP
Model
352/5869
Catalog number
352/5869
Device description
Adult-Pediatric Electrostatic Filter HME with Catheter Mount,Small
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAHFilter, bacterial, breathing-circuit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30884522012359PackageGS125In Commercial Distribution
10884522027946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088452201235930884522012359
1088452202794610884522027946

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;
Special Storage Condition, Specify00Fragile, Keep dry, This side up

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521091986NellcorSC-A-I2026-05-25
20884521841724Shiley50FXLTCP2026-03-17
20884521841687Shiley50FXLTCD2026-03-16
20884521841694Shiley60FXLTCD2026-03-16
20884521841700Shiley70FXLTCD2026-03-16
20884521841717Shiley80FXLTCD2026-03-16
20884521841731Shiley60FXLTCP2026-03-16
20884521841748Shiley70FXLTCP2026-03-16
20884521841755Shiley80FXLTCP2026-03-16
20884521841762Shiley50FXLTUD2026-03-16
20884521841779Shiley60FXLTUD2026-03-16
20884521841786Shiley70FXLTUD2026-03-16
20884521841793Shiley80FXLTUD2026-03-16
20884521841809Shiley50FXLTUP2026-03-16
20884521841816Shiley60FXLTUP2026-03-16
20884521841823Shiley70FXLTUP2026-03-16
20884521841830Shiley80FXLTUP2026-03-16
30884521841844Shiley50FXLTIN2026-03-16
20884521841854Shiley60FXLTIN2026-03-16
20884521841861Shiley70FXLTIN2026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06950743609432Breathing Circuit Bacterial/Viral FilterShaoxing Haitech Medical Products Co., LtdCAH2026-05-23
04716770701127HME W/Luer lock port (Dead space 45ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
04716770701158Angled HME with luer lock portBESMED HEALTH BUSINESS CORP.CAH2026-02-11
04716770702230Bacterial Filter (Dead space 32ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703029HMEF W/Luer lock port (Dead space 45ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703036HMEF W/Luer lock port (Dead space 60ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703067HMEF (Dead space 60ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
30889483228108Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228115Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228122Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228139Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228146Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228153Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228160Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228177Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228207Cardinal HealthSUNMED, LLCCAH2025-12-31
20889483229740BlockAide™SUNMED, LLCCAH2025-12-31
20889483231675Vital Signs™SUNMED, LLCCAH2025-12-31
20889483233198Vital Signs™SUNMED, LLCCAH2025-12-31
20889483233891Vital Signs™SUNMED, LLCCAH2025-12-31
20889483231750PRO-NOX™SUNMED, LLCCAH2025-12-30
20889483232306Vital Signs™SUNMED, LLCCAH2025-12-30
20889483232849Vital Signs™SUNMED, LLCCAH2025-12-30
20889483233389Vital Signs™SUNMED, LLCCAH2025-12-30
20889483234195Vital Signs™SUNMED, LLCCAH2025-12-30
20889483221188Vital Signs™SUNMED, LLCCAH2025-12-23
20889483222543Vital Signs™SUNMED, LLCCAH2025-12-23
20889483226787Vital Signs™SUNMED, LLCCAH2025-12-23
20889483230487Vital Signs™SUNMED, LLCCAH2025-12-23
20889483231163Vital Signs™SUNMED, LLCCAH2025-12-23