FDA.reportPublic FDA data

caina

Primary DI
16971564462317
Brand
caina
Company
Jiangsu Caina Medical Co.,Ltd
Model
"21Gx1 1/4"""
Catalog number
BC062130-W
Device description
Safety Blood Collection Needle
Published
2025-05-14
Public version status
New
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
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200027000Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample AdapterJiangsu Caina Medical Co.,Ltd2020-09-09JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26971564462314PackageGS1100In Commercial Distribution
16971564462317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2697156446231426971564462314
1697156446231716971564462317

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection tube holder/needleA sterile, hand-held cylindrical device with a pre-attached needle designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor with a pre-attached blood collection needle at one end and into which the blood collection tube is inserted at the other end; this also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.

Regulatory Flags#

DUNS number
544543513
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
46971564464336CAINA"21Gx3/4"""2026-04-14
46971564464343CAINA1mL2026-04-14
06971564465021CAINA25501CA2552020-09-20
06971564465038CAINA25701CA2572020-09-20
06971564465045CAINA323501CA32352020-09-20
06971564465052CAINA325501CA32552020-09-20
06971564465069CAINA125501CA12552020-09-20
06971564465076CAINA123501CA12352020-09-20
06971564465083CAINA320501CA32052020-09-20
06971564465090CAINA322701CA32272020-09-20
06971564465106CAINA25G*5/8-01CA2532020-11-10
06971564465113CAINA1ml LL 30G*1/2-01CA13022020-11-10
06971564465120CAINA3ml LL 21G*1-01CA32152020-11-10
06971564465137CAINA3ml LL 22G*1-01CA32252020-11-10
06971564465144CAINA3ml LL 25G*5/8-01CA32532020-11-10
06971564465151CAINA325502CN32552020-12-01
06971564465175CAINA3ml LL 23G*1-02CN323102021-01-15
06971564465182CAINA3ml LL 23G*1.5-02CN323152021-01-15
06971564465199CAINA3ml LL 25G*1.5-02CN325152021-01-15
06971564465205CAINA1ml LL 23G*1-02CN123102021-01-15

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