AccessGUDID - DEVICE: Decloaking Chamber™ NxGen (00847627023506)

GUDID

Device Identifier (DI) Information

Brand Name: Decloaking Chamber™ NxGen
Version or Model: DC2012
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOCARE MEDICAL LLC

Primary DI Number: 00847627023506
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 806617825 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
66288	Pressurized incubator IVD	An electrically-powered pressurized heating chamber intended to be used for the incubation of laboratory specimens for subsequent in vitro diagnostic procedures [e.g., heat-induced epitope retrieval (HIER) and deparaffinization for immunohistochemistry]. It is typically in the form of a pot, similar to a pressure cooker, with a lid and a removable inner liner, where samples are placed in a holder or tray for heating. It is programmable with dedicated software to control settings for temperature, pressure, and incubation time.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPA	Slide Stainer, Automated

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d042e18c-9d62-45aa-8025-d91b1f56ab54
Public Version Date: December 15, 2022
Public Version Number: 1
DI Record Publish Date: December 07, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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