FDA.reportPublic FDA data

Medis

Primary DI
16920687310494
Brand
Medis
Company
Tianjin Medis Medical Device Co.,Ltd.
Model
NF408
Catalog number
NF408
Device description
With O2 Port, Respiratory Indicator, Filter, Orange Connector, Soft Tip and 15mm Connector 8.0mm
Published
2024-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTQAirway, Nasopharyngeal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTQAirway, NasopharyngealAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16920687310494PackageGS110In Commercial Distribution
26920687310491PackageGS110In Commercial Distribution
06920687310497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1692068731049416920687310494
2692068731049126920687310491
06920687310497069206873104976920687310497

GMDN Terms#

Term, Definition table
TermDefinition
Nasopharyngeal airway, single-useA rubber or plastic tube that extends into the pharynx from either naris to maintain airway patency. The proximal end of the device may have an integral 22 mm connector for oxygen delivery. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529125266
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06920687310411MedisNF404NF4042024-09-30
06920687310497MedisNF408NF4082024-09-30
06920687310510MedisNF409NF4092024-09-30
16920687310418MedisNF404NF4042024-09-30
16920687310517MedisNF409NF4092024-09-30
06920687300146MedisNF1042023-09-07
06920687300153MedisNF1052023-09-07
06920687300160MedisNF1062023-09-07
06920687300177MedisNF1072023-09-07
06920687300184MedisNF1082023-09-07
06920687300191MedisNF1092023-09-07
06920687300207MedisNF2042023-09-07
06920687300214MedisNF2052023-09-07
06920687300221MedisNF2062023-09-07
06920687300238MedisNF2072023-09-07
06920687300245MedisNF2082023-09-07
06920687300252MedisNF2092023-09-07
06920687308432MedisNF4142023-09-07
06920687308449MedisNF4152023-09-07
06920687308456MedisNF4162023-09-07

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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