FDA.report

TESTL LUNG 1L (BLUE),W/O LOGO

Primary DI
04716770941004
Brand
TESTL LUNG 1L (BLUE),W/O LOGO
Company
BESMED HEALTH BUSINESS CORP.
Model
TL-94100
Device description
TESTL LUNG 1L (BLUE),W/O LOGO
Published
2017-12-29
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
false

Related Records

Product Codes

CodeName
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications

CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04716770941004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04716770941004047167709410044716770941004

GMDN Terms

TermDefinition
Lung simulatorA device used to simulate/mimic the human lung or lungs by imitating their physical properties. This device, commonly known as a test lung, may be a simple ventilation bag filled with foam rubber, or a complicated device, usually mechanical, that can be adjusted to imitate, e.g., change in compliance, airway restrictions, lung perforation. It is intended to be used by a healthcare provider in a clinical setting for the purpose of, e.g., maintenance, testing, user control of a ventilator and for the education of clinical staff.

Sterilization Methods

Method

Regulatory Flags

DUNS number
658023775
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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