FDA.reportPublic FDA data

Sil-Flex

Primary DI
04710810083303
Brand
Sil-Flex
Company
GaleMed Xiamen Co., Ltd.
Model
77015
Device description
Sil-Flex tube 10F/22F，14cm
Published
2015-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24710810083307PackageGS150In Commercial Distribution
44710810083301PackageGS14In Commercial Distribution
04710810083303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2471081008330724710810083307
4471081008330144710810083301
04710810083303047108100833034710810083303

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit catheter mount, reusableA device designed to connect a respiratory circuit (e.g., an anaesthesia breathing circuit or ventilator breathing circuit) or a resuscitator to an endotracheal (ET) tube, to enable increased mobility at the patient end of the circuit or connections. It most commonly consists of a 22 mm female adaptor at the proximal end that is attached to a short length of corrugated, flexible tube (e.g., 150 mm long), and a straight or angled 15 mm male connector at the distal end which may have a suction port included. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Regulatory Flags#

DUNS number
527333326
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06923980102776N/AAO00932026-09-22
06923980102783N/AAO00942026-09-22
06923980106026N/AAO00922026-09-22
06923980116179N/AAB05092026-08-19
06923980116186N/AAB05102026-08-19
06923980116193N/AAB05112026-08-19
06923980116209N/AAB05122026-08-19
06923980101922N/AAW0005AW00052023-08-16
06923980101939N/AAW0006AW00062023-08-16
06923980102028N/AAW0007AW00072023-08-16
06923980103629N/AAC01352026-07-28
06923980107672N/AAC01422026-07-28
06923980111969N/AAC01602026-07-28
06923980111907MindrayXMR00512026-05-26
06923980112546MindrayXMR00662026-05-26
06923980112577MindrayXMR00242026-05-26
06923980112584MindrayXMR00262026-05-26
06923980112591MindrayXMR01012026-05-26
06923980112607MindrayXMR01022026-05-26
06923980112614MindrayXMR00522026-05-26

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