FDA.report

SourceMark

Primary DI
00897392000776
Brand
SourceMark
Company
Sourcemark, Llc.
Model
M0334
Published
2016-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
false

Related Records

Product Codes

CodeName
CAEAirway, Oropharyngeal, Anesthesiology

Product Code Classifications

CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10897392003156PackageGS120In Commercial Distribution
00897392000776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1089739200315610897392003156
00897392000776008973920007768973920007760897392000776

GMDN Terms

TermDefinition
Laryngeal mask airway, reusableA curved tube with a distal inflatable cuff/mask intended to be used in inhalational anaesthesia and resuscitation to facilitate and secure airway patency for the delivery and exchange of gases in spontaneously breathing and ventilated patients. It is inserted into the hypopharynx above the glottis to create a seal and to prevent the tongue from obstructing the anatomical airway. It may include a 15 mm connector that attaches to a breathing circuit or manual resuscitator, be radiopaque, and have a built-in pilot balloon for cuff pressure monitoring. It is available in various sizes/designs and is typically made of silicone/plastic materials. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
121225812
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

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10813799003612SourceMark SLMIL202020-12-04
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10813799006774SourceMark SMC400-MP-M2020-12-04
10813799006804SourceMark SMC400-P-M2020-12-04
10813799003735SourceMark CV2BL2020-07-21
10813799003766SourceMark CV3BL2020-07-21
10813799003797SourceMark CV4BL2020-07-21
00813799003813SourceMark CV3LH2020-07-21

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