FDA.reportPublic FDA data

Procedural Oxygen Mask

Primary DI
10851438008178
Brand
Procedural Oxygen Mask
Company
POM MEDICAL, LLC
Model
1001-MM-MED
Catalog number
1001-MM-MED-30
Device description
Medium Sized High Concentration Procedural Oxygen Mask
Published
2023-03-06
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYGMask, Oxygen
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172365000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172365000Panoramic Oxygen Mask (POM)Pom Medical, LLC2018-04-19CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851438008178PackageGS130In Commercial Distribution
00851438008171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085143800817810851438008178
00851438008171008514380081718514380081710851438008171

GMDN Terms#

Term, Definition table
TermDefinition
Non-rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of soft, flexible polymers designed to create an airtight seal against the patient's face. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(805) 306-2105info@pommedical.net
+0018002533210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
078731530
Device count
1
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10851438008161Procedural Oxygen Mask1001-MED1001-MED-302023-03-06
10851438008185Procedural Oxygen Mask1001-MF-MED1001-MF-MED-302023-03-06
10851438008192Procedural Oxygen Mask1001-MSA-MED1001-MSA-MED-302023-03-06
10851438008208Procedural Oxygen Mask1003-MED1003-MED-302023-03-06
10851438008215Procedural Oxygen Mask1003-MM-MED1003-MM-MED-302023-03-06
10851438008222Procedural Oxygen Mask1003-MF-MED1003-MF-MED-302023-03-06
10851438008239Procedural Oxygen Mask1003-MSA-MED1003-MSA-MED-302023-03-06

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