FDA.report

SourceMark

Primary DI
10813799003018
Brand
SourceMark
Company
SOURCEMARK, LLC.
Model
M0361
Published
2020-07-08
Public version status
New
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
10813799003018PackageGS110In Commercial Distribution
20813799003022PackageGS14In Commercial Distribution
00813799003004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081379900301810813799003018
2081379900302220813799003022
00813799003004008137990030048137990030040813799003004

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00813799002748SourceMark CV3WF2022-02-24
00813799002861SourceMark CV1002022-02-24
00813799002878SourceMark CVST12022-02-24
00813799003349SourceMark SLH022020-12-04
10813799003377SourceMark SLMAC102020-12-04
10813799003407SourceMark SLMAC202020-12-04
10813799003438SourceMark SLMAC302020-12-04
10813799003490SourceMark SLMAC402020-12-04
10813799003520SourceMark SLMIL002020-12-04
10813799003551SourceMark SLMIL02020-12-04
10813799003582SourceMark SLMIL102020-12-04
10813799003612SourceMark SLMIL202020-12-04
10813799003643SourceMark SLMIL302020-12-04
10813799003674SourceMark SLMIL402020-12-04
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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