RegenLab USA

Primary DI
00850033131086
Brand
RegenLab USA
Company
Regenlab USA LLC
Model
R-ET
Published
2023-04-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850033131086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033131086008500331310868500331310860850033131086

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, noninvasiveA collection of sterile, noninvasive devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes and a separate blood access device (e.g., intravenous catheter), for the routine collection of multiple blood specimens from a patient, for clinical analyses. It consists of various device combinations that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder; the set may connect to, but does not contain, an invasive blood access device(s) [e.g., an intravenous catheter]. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
087434117
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850033131178RegenKit-ATS-T-URK-ATS-T-U2025-10-31
00850033131185RegenKit-ATS-3-URK-ATS-3-U2025-10-31
00850033131215RegenKit®-BCT-T-URK-BCT-T-U2026-03-25
00850033131208RegenKit®-THT-T-URK-THT-T-U2026-03-23
00850033131055RegenLab USARK-THT-3-U 2023-04-28
08500331310042RegenKit®-BCT-TRK-BCT-T2021-08-27
00850033131192Cellular MembraneCM-HA-1CM-HA-12025-12-04
00850033131116Enhanced HASE-EN-HA-12025-08-29
00850033131123Wound Care Accessory SetWCA-SET12025-08-08
00850033131109RegenLab USARK-THT-BMC-3-102024-04-18
00850033131093RegenKit Wound-GelRK-WG-1SE-RK-WG-12024-03-12
00850033131031RegenLab USARK-BCT-3-U 2023-04-28
00850033131048RegenLab USARK-BCT-3-20-U2023-04-28
00850033131062RegenLab USARK-THT-3-20-U2023-04-28
00850033131079RegenLab USARK-WG-22023-04-28
00850033131024Accessory SetBCA-SET3-U2021-11-24
00850033131017Accessory SetBCA-SET3-202021-11-19
08500331310028Accessory SetBCA-SET3-U2021-10-22
08500331310035Accessory SetBCA-SET3-202021-10-22
08500331310011A-CP-Kit-3A-CP-32021-08-27