FDA.reportPublic FDA data

Rospital Productos Medicos

Primary DI
10812460028152
Brand
Rospital Productos Medicos
Company
ATLAS MEDICAL PRODUCTS LLC
Model
AMP19102
Catalog number
AMP19102
Device description
OXYGEN MASK W/TUBING, CHILD. EA.
Published
2020-09-29
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
BYGMask, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812460028152PackageGS150In Commercial Distribution
00812460028155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081246002815210812460028152
00812460028155008124600281558124600281550812460028155

GMDN Terms#

Term, Definition table
TermDefinition
Rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is made of non-conductive, soft, flexible polymers available in a range of sizes, and designed to create an airtight seal against the patient's face. The device may include tubing and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery; other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. 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
00812460027035Rospital Productos MedicosSY10WNSY10WN2020-06-13
00812460027059Rospital Productos MedicosSY10215SY102152020-06-13
00812460020777Rospital Productos MedicosGS4021262022-10-21
00812460020821Rospital Productos MedicosCW500101CW5001012022-10-21
00812460021965Rospital Productos MedicosGS4021284021282022-10-21
00812460025086Rospital Productos MedicosGS402122GS4021222022-10-21
00812460028131Rospital Productos MedicosFM3501FM35012020-09-29
00812460020395ROSPITAL PRODUCTOS MEDICOSELSELS2024-08-23
10812460020392ROSPITAL PRODUCTOS MEDICOSELSELS2024-08-23
00812460021484ROSPITAL PRODUCTOS MEDICOSELSPELSP2024-08-23
00812460024799ROSPITAL PRODUCTOS MEDICOSESPWHESPWH2024-08-23
00812460024768Rospital Producos MedicosSY05WN31516SY05WN315162024-04-16
00812460024775Rospital Productos MedicosSY05WN32516SY05WN325162024-04-16
00812460024782Rospital Productos MedicosSY05WN3012SY05WN30122024-04-16
00812460026243Rospital Productos MedicosSY1WN32516SY1WN325162024-04-16
00812460026274Rospital Productos MedicosSY1WN3012SY1WN30122024-04-16
00812460026298Rospital Productos MedicosSY1WN31516SY1WN315162024-04-16
10812460024765Rospital Producos MedicosSY05WN31516SY05WN315162024-04-16
10812460024772Rospital Productos MedicosSY05WN32516SY05WN325162024-04-16
10812460024789Rospital Productos MedicosSY05WN3012SY05WN30122024-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501379LARYNGEAL MASK Single Use Size 2ASSOMEDIKA, OOOBYG2026-05-27
04816415501386LARYNGEAL MASK Single Use Size 3ASSOMEDIKA, OOOBYG2026-05-27
04816415501393LARYNGEAL MASK Single Use Size 5ASSOMEDIKA, OOOBYG2026-05-27
08697645018129ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018136ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018143ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
09420012427632Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
09420012428585Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
10885632467400HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467417HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467462HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10889483221662Performance Home MedicalSUNMED, LLCBYG2025-12-31
10889483227268BiFLo™SUNMED, LLCBYG2025-12-30
10889483227275BiFLo™SUNMED, LLCBYG2025-12-30
10889483223970AirLife™SUNMED, LLCBYG2025-12-19
10889483224151AirLife™SUNMED, LLCBYG2025-12-19
10889483224298DeVilbissSUNMED, LLCBYG2025-12-19
10889483224687AirLife™SUNMED, LLCBYG2025-12-19
10889483224168AirLife™SUNMED, LLCBYG2025-12-18
10197344011117HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011742HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011759HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011773HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344042203HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011582HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011599HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011605HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011612HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344009626HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-06
10197344010646HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-06