FDA.reportPublic FDA data

RELI

Primary DI
00386120014135
Brand
RELI
Company
MYCO MEDICAL SUPPLIES INC.
Model
SBCN-R20G114
Device description
"Safety Blood Collection Needle 20G x 1.25"", 48/BX, 50BX/CS"
Published
2025-11-21
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
10386120014132PackageGS148In Commercial Distribution
20386120014139PackageGS150In Commercial Distribution
00386120014135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038612001413210386120014132
2038612001413920386120014139
00386120014135003861200141353861200141350386120014135

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.25Inch
Needle Gauge20Gauge

Regulatory Flags#

DUNS number
879187821
Device count
1
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
00386120015088RELI®SST-35W2026-10-01
00386120005669RELIPT7773-SI2015-10-24
00386120006314RELIPT1001-SI2016-04-15
00386120006321RELIPT1002-SI2016-04-15
00386120007854RELIPT556-PPT556-P2017-10-18
00386120008196RELI®PT556-MPT556-M2019-05-13
00386120009735RELI®PT1001-MPT1001-M2019-05-13
00386120009742RELI®PT1002-MPT1002-M2019-05-13
00386120009773RELI®PT7773-MPT7773-M2019-05-13
00386120014227RELI®SBCS21G-122026-02-02
00386120014234RELI®SBCS23G-122026-02-02
00386120014241RELI®SBCS25G-122026-02-02
10386120014224RELI®SBCS21G-122026-02-02
10386120014231RELI®SBCS23G-122026-02-02
10386120014248RELI®SBCS25G-122026-02-02
00386120014128RELISBCN-R20G1012025-11-21
00386120014142RELISBCN-R20G1512025-11-21
00386120014159RELISBCN-R21G1012025-11-21
00386120014166RELISBCN-R21G1142025-11-21
00386120014173RELISBCN-R21G1512025-11-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B098AMS188500Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
B098AMS188510Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
B098AMS188520Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
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16972857299313Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
00050428167243TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
00050428167267TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
06958697621821One+Step INSULIN PEN NEEDLEANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTDFMI2026-10-01
06971564461696ITLJiangsu Caina Medical Co.,LtdJKA2026-09-30
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