FDA.report

1A CHAMBER

Primary DI
B91711406
Brand
1A CHAMBER
Company
PATEJIM S.R.L.
Model
YOUTH
Catalog number
11406
Device description
PREMIUM DOUBLE VALVE HOLDING CHAMBER WITH YOUTH 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
B91711406PrimaryHIBCC0

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
B9171140111A CHAMBERADULT114012021-11-25
B917114021A CHAMBERBREASTFEEDING BABY114022021-11-25
B917114031A CHAMBERINFANT114032021-11-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850079671010NavägeRhinosystems, Inc.CCQ2026-03-02
24026704714524LMA ATOMIZATIONTELEFLEX INCORPORATEDCCQ2025-12-08
06945040110637CONTECContec Medical Systems Co., Ltd.CCQ2025-08-12
06973134772126silverfoxSilverfox Corporation LimitedCCQ2025-01-06
00840183528423BR Surgical, LLCBR Surgical, LLCCCQ2024-11-07
50628725098208VixOne™ Nebulizer Kit Canadian Hospital Specialties LimitedCCQ2024-08-20
10851440007725Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
10851440007732Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
10851440007749Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
00810094577179CuraplexBOUND TREE MEDICAL, LLCCCQ2024-07-30
00840183522018BR Surgical, LLCBR Surgical, LLCCCQ2024-07-23
00840183524128BR Surgical, LLCBR Surgical, LLCCCQ2024-07-23
00840183525255BR Surgical, LLCBR Surgical, LLCCCQ2024-07-23
00840183526689BR Surgical, LLCBR Surgical, LLCCCQ2024-07-23
06971066425639FOFOFoshan Hongfeng Co., Ltd.CCQ2024-06-06
06971066426384FOFOFoshan Hongfeng Co., Ltd.CCQ2024-06-06
06971066428340FOFOFoshan Hongfeng Co., Ltd.CCQ2024-06-06
06971066429736FOFOFoshan Hongfeng Co., Ltd.CCQ2024-06-06
06971066429439FOFOFoshan Hongfeng Co., Ltd.CCQ2024-06-05
50628725096945Nebulizer KitCanadian Hospital Specialties LimitedCCQ2024-02-23
00840117326965Empty Humidifier ( Jet ) NebulizerDYNAREX CORPORATIONCCQ2023-12-28
06973134772034silverfoxSilverfox Corporation LimitedCCQ2023-12-14
06973134772041silverfoxSilverfox Corporation LimitedCCQ2023-12-14
06973134772058silverfoxSilverfox Corporation LimitedCCQ2023-12-14
06973134772065silverfoxSilverfox Corporation LimitedCCQ2023-12-14
06973134772072silverfoxSilverfox Corporation LimitedCCQ2023-12-14
06973134772089silverfoxSilverfox Corporation LimitedCCQ2023-12-14
06973134772096silverfoxSilverfox Corporation LimitedCCQ2023-12-14
06973134772102silverfoxSilverfox Corporation LimitedCCQ2023-12-14
06973134772218silverfoxSilverfox Corporation LimitedCCQ2023-12-14