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
00840118621137Endure IndustriesOMEP11OMEP112026-08-17
00840118600361Endure IndustriesNDAFC211NDAFC2112026-08-14
00840118602150Endure IndustriesECAKCDQ-118ECAKCDQ-1182026-08-14
00840118607988Endure IndustriesNCAC211NCAC2112026-08-14
00840118609616Endure IndustriesNDAMC211NDAMC2112026-08-14
00840118614245Endure IndustriesESP38ESP382026-08-14
00840118614252Endure IndustriesESP310ESP3102026-08-14
00840118614269Endure IndustriesESP511ESP5112026-08-14
00840118614276Endure IndustriesESP516ESP5162026-08-14
00840118614283Endure IndustriesESP713ESP7132026-08-14
00840118614290Endure IndustriesESP916ESP9162026-08-14
00840118614306Endure IndustriesESP1118ESP11182026-08-14
00840118614900Endure IndustriesNDAF211NDAF2112026-08-14
00840118616447Endure IndustriesEBSEBS2026-08-14
00840118617338Endure IndustriesNDAM411UNDAM411U2026-08-14
00840118617352Endure IndustriesNDAM411NDAM4112026-08-14
00840118617376Endure IndustriesNDAF411UNDAF411U2026-08-14
00840118617390Endure IndustriesNDAF411NDAF4112026-08-14
00840118617413Endure IndustriesNCPC211NCPC2112026-08-14
00840118617437Endure IndustriesNDPM211NDPM2112026-08-14

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10197344112722MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216116MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
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10197344216185MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
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