FDA.reportPublic FDA data

Zammi

Primary DI
07899043000039
Brand
Zammi
Company
Zammi Instrumental Eireli
Model
11102E
Catalog number
11102E
Device description
ONE-WAY VALVE CHEST DRAINAGE SYSTEM - PHYSIODRAIN 1000 ml
Published
2023-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KDQBottle, Collection, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899043000039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899043000039078990430000397899043000039

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drainage kitA collection of devices designed to remove fluids or purulent material from a closed-wound in a controlled manner. It includes a container (the receptacle or reservoir), drains/catheters, connectors, a grasping device and possibly a trocar for placing the drains/catheters into the site. The reservoir will usually be provided with graduated markers along its side to facilitate the approximate measurement of the collected fluids. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
898759832
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899043000015Zammi751075102023-03-13
07899043000022Zammi751175112023-03-13
07899043000053Zammi11801E11801E2023-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10073088165296BemisBEMIS MANUFACTURING COMPANYKDQ2025-02-07
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