FDA.reportPublic FDA data

CMO8 Adult PMP Oxygenator with Tubing Pack

Primary DI
05060491619810
Brand
CMO8 Adult PMP Oxygenator with Tubing Pack
Company
CHALICE MEDICAL LIMITED
Model
CME40009
Catalog number
CME40009
Device description
The CMO8 Adult PMP Oxygenator with Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
Published
2024-10-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTRHeat-Exchanger, Cardiopulmonary Bypass
DTZOxygenator, Cardiopulmonary Bypass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTRHeat-Exchanger, Cardiopulmonary BypassCardiovascular2
DTZOxygenator, Cardiopulmonary BypassCardiovascular2
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060491619817PackageGS13Not in Commercial Distribution
05060491619810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506049161981715060491619817
05060491619810050604916198105060491619810

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal membrane oxygenation system circuitA complete portable assembly of noninvasive, non-powered devices intended to be used as part of an extracorporeal bypass system to provide short-term or prolonged (i.e., extra-surgical) mechanical circulatory life support during extracorporeal membrane oxygenation (ECMO) [sometimes referred to as extracorporeal lung support (ECLS)]. It usually includes a centrifugal pump mechanism, defoamer, heat exchanger, membrane oxygenator, and integrated tubing or independent tubing sets. It is intended to be used in conjunction with the capital components (e.g., pump drive unit, gas control unit, heating/cooling unit) and invasive components (e.g., cannulae) of the bypass. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00to be stored in a dry, room temperature area and protected from direct solar or UV light.

Contacts#

Phone, Email table
PhoneEmail
+441909470777enquiries@chalicemedical.com

Regulatory Flags#

DUNS number
236289299
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060912587483CMO8 Adult PMP Oxygenator with Tubing PackCME40009CME400092025-02-07
15060491619817CMO8 Adult PMP Oxygenator with Tubing PackCME40009CME400092024-10-07
05060491614129Adult Tubing Pack with Paragon Adult Maxi PMP OxygenatorCME40004CME400042023-11-07
15060491614126Adult Tubing Pack with Paragon Adult Maxi PMP OxygenatorCME40004CME400042023-11-07
05060491617915Paragon Adult Maxi PMP OxygenatorXCMOP405PMPXCMOP405PMP2021-01-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06974762681019LifemotionLifemotion Medical Technology Co., Ltd.DTZ2026-06-02
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08033178017206Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
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