FDA.reportPublic FDA data

NORTH AMERICAN RESCUE

Primary DI
16935550810094
Brand
NORTH AMERICAN RESCUE
Company
Jiangsu Shenli Medical Production Co.,Ltd.
Model
ZZ-0070
Catalog number
ZZ-0070
Device description
NAR 10ml sterile syringe,LUER LOCK,For single use only.
Published
2018-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103830000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103830000JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK)Jiangsu Shenli Medical Production Factory2011-07-29FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26935550810091PackageGS1100In Commercial Distribution
36935550810098PackageGS112In Commercial Distribution
16935550810094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2693555081009126935550810091
3693555081009836935550810098
1693555081009416935550810094

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-689-6277xxx@xx.xx

Regulatory Flags#

DUNS number
420611311
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06935550817010BDS21G×3/4‘’2022-01-26
06935550817027ECLIPSEPRPB-3686522022-03-11
06935550810035Tianzi1ml2021-08-02
06935550810103ECLIPSEPRP2600-10ML2022-03-11
06935550810110Tianzi20ML2020-12-05
06935550813012Tianzi10ml2020-12-05
06935550810028NA1ml 2021-02-28
06935550810059DPS3ml2020-12-17
06935550810011DPS1ml2020-11-27
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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Primary DI, Brand, Company table
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