FDA.reportPublic FDA data

ECLIPSE

Primary DI
06935550817027
Brand
ECLIPSE
Company
Jiangsu Shenli Medical Production Co.,Ltd.
Model
PRPB-368652
Device description
Eclipse Blood Collection SetSIZE:21G/19.5mm
Published
2022-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163093000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163093000Safety Blood Collection SetJiangsu Shenli Medical Production Co., Ltd.2017-03-14FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16935550817024PackageGS150In Commercial Distribution
26935550817021PackageGS112In Commercial Distribution
06935550817027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693555081702416935550817024
2693555081702126935550817021
06935550817027069355508170276935550817027

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.

Regulatory Flags#

DUNS number
420611311
Device count
1
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
06935550817010BDS21G×3/4‘’2022-01-26
06935550810035Tianzi1ml2021-08-02
06935550810103ECLIPSEPRP2600-10ML2022-03-11
06935550810110Tianzi20ML2020-12-05
06935550813012Tianzi10ml2020-12-05
06935550810028NA1ml 2021-02-28
06935550810059DPS3ml2020-12-17
06935550810011DPS1ml2020-11-27
16935550810094NORTH AMERICAN RESCUEZZ-0070ZZ-00702018-09-22
06935550812015Tianzi1ml Luer Slip 25G×1‘’01LS252023-02-28
06935550812312Tianzi3ml Luer Lock 23G×1‘’03LL232023-02-28
16935550812012Tianzi1ml Luer Slip 25G×1‘’01LS252023-02-28
16935550812319Tianzi3ml Luer Lock 23G×1‘’03LL232023-02-28
16935550810100ECLIPSEPRP2600-10ML2022-03-11
16935550817024ECLIPSEPRPB-3686522022-03-11
16935550817017BDS21G×3/4‘’2022-01-26
16935550810032Tianzi1ml2021-08-02
06935550812022NA3ml 21G×1''2021-02-28
06935550811025NA23G×1''2021-02-28
16935550812029NA3ml 21G×1''2021-02-28

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