FDA.report

SunMed

Primary DI
10889483039366
Brand
SunMed
Company
SUNMED, LLC
Model
4-0050-50
Catalog number
4-0050-50
Device description
TEST LUNG LATEX FREE GREEN MED
Published
2023-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BTCBAG, RESERVOIR

Product Code Classifications

CodeDeviceSpecialtyClass
BTCBag, ReservoirAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10889483039366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088948303936610889483039366

GMDN Terms

TermDefinition
Lung physical simulatorA mechanical device intended to simulate/mimic the human lung(s) by imitating its 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.

Device Sizes

TypeValueUnit
Total Volume750Milliliter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)433-2797info@sun-med.com

Regulatory Flags

DUNS number
069009268
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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