FDA.report

1A CHAMBER

Primary DI
B917114011
Brand
1A CHAMBER
Company
PATEJIM S.R.L.
Model
ADULT
Catalog number
11401
Device description
PREMIUM DOUBLE VALVE HOLDING CHAMBER WITH ADULT MASK
Published
2021-11-25
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

Product Codes

CodeName
CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)

Product Code Classifications

CodeDeviceSpecialtyClass
CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B917114011PrimaryHIBCC0

GMDN Terms

TermDefinition
Medicine chamber spacer, reusableA device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. It is typically made of plastic materials and in the form of a small tube-like container. By holding the drug(s) after aerosolization (e.g., via an internal valve) this device reduces the direct delivery of large aerosolized particles which would otherwise deposit in the mouth/upper airway, but are intended for the lower airway. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
975299082
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B917104041A CHAMBERMOUTHPIECE104042021-11-25
B917114021A CHAMBERBREASTFEEDING BABY114022021-11-25
B917114031A CHAMBERINFANT114032021-11-25
B917114061A CHAMBERYOUTH114062021-11-25

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