Accessory Set

Primary DI
07640138981449
Brand
Accessory Set
Company
REGEN LAB SA
Model
BCA-SET3-20
Published
2020-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640138981449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640138981449076401389814497640138981449

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
482206518
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640138980794RegenKit®-THT-48495-9-0042016-09-15
07640138981784A-CP-Kit-3 (8ml)A-CP-3-8ml2023-01-20
07640138981616RegenPlasma/RegenKit-Woud Gel-2RK-WG-22023-01-19
07640138981012RegenETR-ET-3x202022-06-28
07640138981630RegenKit-BCT-3 (20ml)/RegenPlasmaRK-BCT-3-202022-04-02
07640138981593RegenKit-THT-3/RegenCell®RK-THT-3-202021-10-26
07640138981487RegenETR-ET-3 x 102020-11-19
07640138980329Accessory Set BCA-SET32020-10-13
07640138981432Accessory Set BCA-SET3-U2020-10-05
07640138981364RegenETR-ET-32020-02-24
07640138980244RegenKit®-THT-1/RegenCell®RK-THT-12019-06-17
07640138980251RegenKit®-THT-4/RegenCell®RK-THT-42019-06-17
07640138980565RegenKit®-THT-2/RegenCell®RK-THT-22019-06-17
07640138980039RegenKit®-BCT-2 PlusRK-BCT-2A2016-09-15
07640138980138RegenKit®-BCT-1 PlusRK-BCT-1A2016-09-15
07640138980190A-CP-Kit-1A-CP-12016-09-15
07640138980220Regen Spray ApplicatorR-A/NAC12016-09-15
07640138980268RegenKit®-BCT-1RK-BCT-12016-09-15
07640138980275RegenKit®-BCT-2RK-BCT-22016-09-15
07640138980282RegenKit®-BCT-4RK-BCT-42016-09-15