FDA.reportPublic FDA data

Juneland

Primary DI
06976143660040
Brand
Juneland
Company
Suzhou Juneland Medical Co., Ltd.
Model
004
Device description
disposable suction tube
Published
2023-04-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JOLCatheter And Tip, Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976143660040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976143660040069761436600406976143660040

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
414758527
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976143661252Juneland0132024-10-21
06976143660057Juneland0052023-04-11
06976143660064Juneland0062023-04-11
06976143660071Juneland0072023-04-11
06976143660088Juneland0082023-04-11
06976143660095Juneland0092023-04-11
06976143660101Juneland0102023-04-11
06976143660118Juneland0112023-04-11
06976143660125Juneland0122023-04-11
06976143660019Juneland0012023-04-07
06976143660026Juneland0022023-04-07
06976143660033Juneland0032023-04-07
06976143660002Juneland0002023-03-23

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Primary DI, Brand, Company table
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