BACTI-SWAB R12300

GUDID 00848838018244

BactiSwab NPG (Mod Stuarts) PK/100

REMEL, INC.

General specimen collection kit IVD, clinical
Primary Device ID00848838018244
NIH Device Record Key3be37894-c8f4-432c-b003-9f1fa1e5c5b0
Commercial Distribution Discontinuation2024-03-28
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBACTI-SWAB
Version Model NumberR12300
Catalog NumberR12300
Company DUNS065769564
Company NameREMEL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848838018244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LIODevice, Specimen Collection

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-03-29
Device Publish Date2022-12-22

On-Brand Devices [BACTI-SWAB]

00848838018282ACT II Dual Transport PK/10
00848838018244BactiSwab NPG (Mod Stuarts) PK/100
00848838018220BactiSwab II (Mod Stuarts) PK/100
00848838018206BactiSwab (Mod Stuarts) PK/100
00848838018190BactiSwab (Dry) PK/100

Trademark Results [BACTI-SWAB]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BACTI-SWAB
BACTI-SWAB
76447402 2717516 Live/Registered
Remel Inc.
2002-09-06

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