FDA.reportPublic FDA data

POM EZ-Lite MM

Primary DI
20851438008106
Brand
POM EZ-Lite MM
Company
STRYKER CORPORATION
Model
1003-MM
Device description
Adult Procedural Oxygen Mask - Medium Concentration & CO2 Monitoring (Male to Male)
Published
2018-07-11
Public version status
Update
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
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
20851438008106PackageGS130In Commercial Distribution
10851438008109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085143800810620851438008106
1085143800810910851438008109

GMDN Terms#

Term, Definition table
TermDefinition
Capnography oxygen maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver oxygen (O2) to a patient's airway, and to sample exhaled respiratory gases for monitoring the patient’s ventilatory status. It includes exhaled air sampling tubing for connection to a carbon dioxide monitor (capnograph), or physiology-monitoring sedation/anaesthesia system, for the measurement of end-tidal carbon dioxide (EtCO2) in expiratory gases; it is typically used during anaesthesia/sedation or bedside monitoring. 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
(855) 766-0202info@pommedical.net
+0018002533210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
196548481
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07613154599158NA59200002075920-000-2072018-09-24
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07613154599196NA59200003025920-000-3022018-09-24
07613154599202NA59200003035920-000-3032018-09-24
07613154599219NA59200003045920-000-3042018-09-24
07613154599226NA59200003055920-000-3052018-09-24
07613154599233NA59200003065920-000-3062018-09-24

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