FDA.reportPublic FDA data

Rospital Productos Medicos

Primary DI
10812460028183
Brand
Rospital Productos Medicos
Company
ATLAS MEDICAL PRODUCTS LLC
Model
AMP18101
Catalog number
AMP18101
Device description
NEBULIZER MASKS, ADULT, W/TUBING & JAR. EA.
Published
2020-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812460028183PackageGS150In Commercial Distribution
00812460028186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081246002818310812460028183
00812460028186008124600281868124600281860812460028186

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system delivery set, single-useA collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7864739436levalenzuela17@gmail.com

Regulatory Flags#

DUNS number
013112308
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10812460020392ROSPITAL PRODUCTOS MEDICOSELSELS2024-08-23
00812460021484ROSPITAL PRODUCTOS MEDICOSELSPELSP2024-08-23
00812460024799ROSPITAL PRODUCTOS MEDICOSESPWHESPWH2024-08-23
10812460024765Rospital Producos MedicosSY05WN31516SY05WN315162024-04-16
10812460024772Rospital Productos MedicosSY05WN32516SY05WN325162024-04-16
10812460024789Rospital Productos MedicosSY05WN3012SY05WN30122024-04-16
10812460026240Rospital Productos MedicosSY1WN32516SY1WN325162024-04-16
10812460026271Rospital Productos MedicosSY1WN3012SY1WN30122024-04-16
10812460026295Rospital Productos MedicosSY1WN31516SY1WN315162024-04-16
10812460021344Rospital Productos MedicosAMPRG361002023-03-17
10812460025045Rospital Productos MedicosSBP22SBP222023-03-17
10812460020774Rospital Productos MedicosGS4021262022-10-21
10812460020828Rospital Productos MedicosCW500101CW5001012022-10-21
10812460021962Rospital Productos MedicosGS4021284021282022-10-21
10812460025083Rospital Productos MedicosGS402122GS4021222022-10-21
10812460026905Rospital Productos MedicosSY2021SY20212020-06-13
10812460026936Rospital Productos MedicosSY325SY3252020-06-13
10812460026943Rospital Productos MedicosSY321SY3212020-06-13
10812460026950Rospital Productos MedicosSY3215SY32152020-06-13
10812460026967Rospital Productos MedicosSY3225SY32252020-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850022483387Dr. Noze Best NebulizerDr. Noze Best, LLCCCQ2026-05-26
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