Regen Spray Applicator

GUDID 08500331310110

Regenlab USA LLC

Haematological concentrate system preparation kit, platelet concentration

Primary Device ID	08500331310110
NIH Device Record Key	1186950a-2ca8-4172-b221-cf1e78d60163
Commercial Distribution Status	In Commercial Distribution
Brand Name	Regen Spray Applicator
Version Model Number	R-A/NAC1
Company DUNS	087434117
Company Name	Regenlab USA LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08500331310110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K122122

FDA Product Code

FMF	Syringe, Piston

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-09-06
Device Publish Date	2021-08-27

Devices Manufactured by Regenlab USA LLC

00850033131109 - RegenLab USA	2024-04-26 RegenKit-THT-BMC, Ref: RK-THT-BMC-3-10
00850033131093 - RegenKit Wound-Gel	2024-03-20 .
00850033131031 - RegenLab USA	2023-05-08
00850033131048 - RegenLab USA	2023-05-08
00850033131055 - RegenLab USA	2023-05-08
00850033131062 - RegenLab USA	2023-05-08
00850033131079 - RegenLab USA	2023-05-08
00850033131086 - RegenLab USA	2023-05-08