FDA.reportPublic FDA data

Medline

Primary DI
10193489010411
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDTNBC21GL
Catalog number
DYNDTNBC21GL
Device description
"BLD COLL SET, 21GX0.75"", INFUSION"
Published
2020-11-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151991000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151991000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10193489010411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019348901041110193489010411

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of sterile 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 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0.75Inch
Needle Gauge21Gauge
Weight21Gram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
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
10884389112090MEDLINEEQX7012EQX70122026-10-09
10884389931967MEDLINEMSC7366EPMSC7366EP2026-10-09
20193489079804MEDLINEBNS128632BNS1286322026-10-09
30193489079726MEDLINEBNS111718BNS1117182026-10-09
30193489079771MEDLINEBNS119386BNS1193862026-10-09
30193489079788MEDLINEBNS119387BNS1193872026-10-09
30193489079795MEDLINEBNS120988BNS1209882026-10-09
10197344104116MEDLINEPIVBCA18125PIVBCA181252025-02-06
10197344104130MEDLINEPIVBCA20100PIVBCA201002025-02-06
10197344104147MEDLINEPIVBCA20125PIVBCA201252025-02-06
20197344024992MedlineMPH22325HCGMPH22325HCG2024-03-11
10197344042388HUDSON RCIHUD1895HUD18952026-10-08
10197344042395HUDSON RCIHUD1896HUD18962026-10-08
10653160394273MEDLINEDYND71006DYND710062026-10-08
10653160394532MEDLINEDT22100ADT22100A2026-10-08
10653160394594MEDLINEDYNDC3490ADYNDC3490A2026-10-08
10653160394709MEDLINEDYNDC3601DYNDC36012026-10-08
10653160394921MEDLINEDYNDC2850ADYNDC2850A2026-10-08
10653160395119MEDLINEDYNDC2762BDYNDC2762B2026-10-08
10653160395270MEDLINEDYNDC2539DDYNDC2539D2026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885403520631BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
10885403533839BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
10885403533846BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
01081633602518WUSA6010NEOCHILD, LLCFPA2026-10-08
10612479285993McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
10612479286013McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
04046955765164IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-27
00884450707104Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
00884450707111Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
04046955114559IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-19
10850083986008TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986015TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986022TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986039TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10813153027339CodanCodan US CorporationFPA2026-07-31
10813153028312CodanCodan US CorporationFPA2026-07-31
10850048235196HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
10813153028329CodanCodan US CorporationFPA2026-07-17
00827989008243MedSafetyHealth Care Logistics, Inc.FPA2026-07-10
00840117349841IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm)Dynarex CorporationFPA2026-06-30