FDA.report

LMA AIRWAY MANAGEMENT

Primary DI
15060112310147
Brand
LMA AIRWAY MANAGEMENT
Company
TELEFLEX INCORPORATED
Model
IPN901666
Catalog number
101050
Device description
LMA™ Cuff Deflator Size 5
Published
2018-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Product Code Classifications

CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15060112310147PackageGS110Not in Commercial Distribution
25060112310144PackageGS15Not in Commercial Distribution
05060112310140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1506011231014715060112310147
2506011231014425060112310144
05060112310140050601123101405060112310140

GMDN Terms

TermDefinition
Laryngeal airway cuff deflatorA non-sterile device intended to aid full deflation of a reusable laryngeal airway cuff in order to allow successful insertion, and efficacious cleaning/sterilization of the laryngeal airway. It may consist of a synthetic mould (e.g., silicone) to which the laryngeal airway cuff compresses and is manually deflated. This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Dark cool environment avoid direct sunlight

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
true
Sterilization required before use
true

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