FDA.reportPublic FDA data

RELI

Primary DI
10386120007417
Brand
RELI
Company
MYCO MEDICAL SUPPLIES INC.
Model
SBCTH-Orange
Catalog number
SBCTH-Orange
Device description
RELI® Safety Blood Collection Tube Holder - Orange
Published
2019-01-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K173279000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173279000RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube HolderMyco Medical Supplies, Inc.2018-05-14FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20386120007414PackageGS116In Commercial Distribution
10386120007417PrimaryGS10
00386120007410Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2038612000741420386120007414
1038612000741710386120007417
00386120007410003861200074103861200074100386120007410

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection tube holder, single-useA hand-held cylindrical device 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 into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.

Regulatory Flags#

DUNS number
879187821
Device count
50
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
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
00386120014135RELISBCN-R20G1142025-11-21
00386120014142RELISBCN-R20G1512025-11-21
00386120014159RELISBCN-R21G1012025-11-21
00386120014166RELISBCN-R21G1142025-11-21
00386120014173RELISBCN-R21G1512025-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08056999020309SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020316SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020323SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020330SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020347SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020354SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020361SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020385SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020408SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
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00840464800033Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800040Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800057Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800064Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
10840330704868ProCureTwin Med, LLCFMI2026-05-27
10840330704875ProCureTwin Med, LLCFMI2026-05-27
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
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08586015044823CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27