FDA.reportPublic FDA data

Pall® Heat and Moisture Exchanger

Primary DI
30636207311291
Brand
Pall® Heat and Moisture Exchanger
Company
PALL CORPORATION
Model
HME40
Catalog number
HME40
Device description
Heat and Moisture Exchanger for patient end use, indicated for airway humidification of patients undergoing mechanical ventilation
Published
2016-06-01
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYDCONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYDCondenser, Heat And Moisture (Artificial Nose)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30636207311291PackageGS150In Commercial Distribution
00636207311290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3063620731129130636207311291
00636207311290006362073112906362073112900636207311290

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger, single-useA one-piece, canister-like device that connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube], to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an "artificial nose", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)645-6578QAMedical@pall.com

Regulatory Flags#

DUNS number
002054419
Device count
1
DM exempt
true
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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30636207302435Pall® CellWash/Infusion Bag Set791-03791-032016-06-01
30636207302442Pall® Transfer/Freezing Bag Set791-02791-022016-06-01
30636207302466Pall® Freezing Bag 25 mL with Separable Chamber791-05791-052016-06-01
30636207314681Briostor™ Transfer/Freezing Bag Set791-12791-122016-07-20
30636207315398Ultipor™ Anesthesia Breathing Circuit System - CO2 Monitoring LineCO2GSL060CO2GSL0602016-06-29
30636207315336Gas Sampling Elbow with CapWMPELBOVMPELBO2016-06-29
30636207300905Pall Posidyne® NEO FilterNEO96NEO962016-06-01
30636207300936Pall Posidyne® NEO FilterNEO96NYNEO96NY2016-06-01
30363207000244Pall® Breathing Circuit FilterBB50TBB50T2016-06-01
35034480004056Pall LeukoGuard LGBLGBLGB2015-10-21
30636207000126Pall Posidyne® ELD FilterELD96NTELD96NT2016-06-01
30636207000232Pall Conserve™ Small Volume HMEBB25ABB25A2016-06-01
30636207000324Pall Posidyne® ELD FilterELD96LLELD96LL2016-06-01
30636207000331Pall Posidyne® ELD FilterELD96LYLELD96LYL2016-06-01
30636207000348Pall Posidyne® ELD FilterELD96LYLSELD96LYLS2016-06-01
30636207000690Pall® Total Nutrient Admixture FilterTNA1TNA12016-06-01
30636207000744Pall Ultipor™ 100 Breathing System FilterBB100ABB100A2016-06-01
30636207300684Pall Ultipor™ 100 Breathing System FilterBB100AFBB100AF2016-06-01
30636207300691Pall Ultipor™ 100 Breathing System FilterBB100APFBB100APF2016-06-01

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