FDA.reportPublic FDA data

Endure

Primary DI
00840118604109
Brand
Endure
Company
ENDURE INDUSTRIES
Model
SB213A4-0520
Catalog number
SB213A4
Device description
Safety Blood Collection Set, 21G, 3/4", Sterile
Published
2020-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840118604109PackageGS1100In Commercial Distribution
00840118604116PackageGS120In Commercial Distribution
00840118604093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118604109008401186041098401186041090840118604109
00840118604116008401186041168401186041160840118604116
00840118604093008401186040938401186040930840118604093

GMDN Terms#

Term, Definition table
TermDefinition
Venous butterfly needle/setAn invasive, hollow, tubular, metal device intended to puncture a vein to collect blood and/or for transient (<24 hours) or short-term (<= 30 days) administration of intravenous (IV) fluids. It includes wings for fixation/placement and may include tubing and/or connectors; however, it does not include accessories to facilitate introduction (e.g., stylet). The device may also be referred to as butterfly needle or scalp vein needle. This is a single-use device.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius49 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6072994971Support@endureind.com

Regulatory Flags#

DUNS number
066087031
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840118600507EndureSP11A3-0520SP11A32020-11-19
00840118600538EndureSP21A3-0520SP21A32020-11-19
00840118600569EndureSP22A3-0520SP22A32020-11-19
00840118600590EndureSP31A3-0520SP31A32020-11-19
00840118600620EndureSP41A3-0520SP41A32020-11-19
00840118600651EndureSP42A3-0520SP42A32020-11-19
00840118600682EndureSP61A3-0520SP61A32020-11-19
00840118600712EndureSP62A3-0520SP62A32020-11-19
00840118600743EndureSP81A3-0520SP81A32020-11-19
00840118614566ENDURE INDUSTRIESIDABA8IDABA82024-10-04
00840118614597ENDURE INDUSTRIESIDAPA8IDAPA82024-10-04
00840118617840ENDURE INDUSTRIESUB1GA9UB1GA92024-04-17
00840118617871ENDURE INDUSTRIESUB2LA9UB2LA92024-04-17
00840118606660ENDURE INDUSTRIESCBP150A8CBP150A82024-04-10
00840118606684ENDURE INDUSTRIESCB70A8CB70A82024-04-10
00840118606707ENDURE INDUSTRIESCBTA8CBTA82024-04-10
00840118608077ENDURE INDUSTRIESNROMP11NROMP112024-04-10
00840118615297ENDURE INDUSTRIESGS13GS132024-04-10
00840118609722ENDURE INDUSTRIESWSS44WSS442024-04-10
00840118611619ENDURE INDUSTRIESNROMPE11NROMPE112024-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10386120014224RELI®MYCO MEDICAL SUPPLIES INC.JKA2026-02-02
10386120014231RELI®MYCO MEDICAL SUPPLIES INC.JKA2026-02-02
10386120014248RELI®MYCO MEDICAL SUPPLIES INC.JKA2026-02-02
00810184642213GCB Medical SupplyGCB MEDICAL LLCJKA2026-01-28
00810184642220GCB Medical SupplyGCB MEDICAL LLCJKA2026-01-28
00810184642237GCB Medical SupplyGCB MEDICAL LLCJKA2026-01-28
50382903678438BD Vacutainer® K2 EDTA (K2E) 3.6mg Blood Collection TubesBECTON, DICKINSON AND COMPANYJKA2026-01-27
20197344132918MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-01-23
20197344132925MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-01-23
00850073657041Navi Needle-free Blood Collection DeviceVenocare, Inc.JKA2026-01-20
00850073657065Navi Needle-free Blood Collection DeviceVenocare, Inc.JKA2026-01-20
10850073657024Navi Needle-free Blood Collection DeviceVenocare, Inc.JKA2026-01-20
00850073657027Navi Needle-free Blood Collection DeviceVenocare, Inc.JKA2026-01-20
20850074089067SurgycoSurgyco LLCJKA2025-12-23
20850074089074SurgycoSurgyco LLCJKA2025-12-23
20850074089081SurgycoSurgyco LLCJKA2025-12-23
20850074089098SurgycoSurgyco LLCJKA2025-12-23
20850074089104SurgycoSurgyco LLCJKA2025-12-23
20850074089111SurgycoSurgyco LLCJKA2025-12-23
00850058457031BD MiniDraw Capillary Tube Adapter SSTBabson Diagnostics, Inc.JKA2025-12-09
30351688010180PortexICU MEDICAL, INC.JKA2025-11-24
04038917983259S-Monovette® 1.6ml Serum CATSarstedt Aktiengesellschaft & Co.KGJKA2025-09-25
04038917983280S-Monovette® 1.6ml Serum CATSarstedt Aktiengesellschaft & Co.KGJKA2025-09-25
04038917983310S-Monovette® 1.6ml Serum CATSarstedt Aktiengesellschaft & Co.KGJKA2025-09-25
04038917983372S-Monovette® 1.6ml LHSarstedt Aktiengesellschaft & Co.KGJKA2025-09-25
040389179834021,6ml S-Monov. LiI-HEPSarstedt Aktiengesellschaft & Co.KGJKA2025-09-25
04038917983433S-Monovette® 1.6ml LHSarstedt Aktiengesellschaft & Co.KGJKA2025-09-25
20612479275649McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
20612479275670McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
20612479275700McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14