FDA.report

Endure

Primary DI
00840118604192
Brand
Endure
Company
ENDURE INDUSTRIES
Model
SBH233A4-0520
Catalog number
SBH233A4
Device description
Safety Blood Collection Set with Holder, 23G, 3/4", Sterile
Published
2021-07-25
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

Related Records

Contact Domains

Product Codes

CodeName
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications

CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840118604192PackageGS150In Commercial Distribution
00840118604208PackageGS120In Commercial Distribution
00840118604185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118604192008401186041928401186041920840118604192
00840118604208008401186042088401186042080840118604208
00840118604185008401186041858401186041850840118604185

GMDN Terms

TermDefinition
Blood collection set, invasiveA collection of 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 or venous butterfly/scalp vein 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

TypeValueUnit
Catheter Length0.75Inch
Needle Gauge23Gauge

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius49 Degrees Celsius

Sterilization Methods

Method

Contacts

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

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00840118606684ENDURE INDUSTRIESCB70A8CB70A82024-04-10
00840118606707ENDURE INDUSTRIESCBTA8CBTA82024-04-10
00840118608077ENDURE INDUSTRIESNROMP11NROMP112024-04-10
00840118615297ENDURE INDUSTRIESGS13GS132024-04-10
00840118609722ENDURE INDUSTRIESWSS44WSS442024-04-10
00840118611619ENDURE INDUSTRIESNROMPE11NROMPE112024-04-10

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