FDA.report

LMA AIRWAY MANAGEMENT

Primary DI
35060112317751
Brand
LMA AIRWAY MANAGEMENT
Company
TELEFLEX INCORPORATED
Model
IPN922792
Catalog number
1F8010
Device description
LMA(R) Unique(TM) (Silicone Cuff) Cuff Pilot(TM) With Accessories Size 1
Published
2022-03-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Product Code Classifications

CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
25060112317754PackageGS110In Commercial Distribution
35060112317751PackageGS15In Commercial Distribution
15060112317757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2506011231775425060112317754
3506011231775135060112317751
1506011231775715060112317757

GMDN Terms

TermDefinition
Laryngeal mask airway, single-useA 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 single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Dark cool environment avoid direct sunlight
Special Storage Condition, Specify00Dark cool environment, avoid direct sunlight.

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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