AccessGUDID - DEVICE: BD Pre-warm Heater (00382904431594)

GUDID

Device Identifier (DI) Information

Brand Name: BD Pre-warm Heater
Version or Model: 443159
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 443159
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904431594
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: KIT PREWARM MAX6

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?
46944	Test tube heater	An electrically-powered device used in the laboratory to hold and maintain at specific temperatures test tubes containing a fluid specimen (e.g., cell samples). The device typically contains several slots to hold test tubes upright, and its heating element is controlled electronically to reliably maintain a physiological temperature.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OOI	real time Nucleic acid amplification system
PCH	Gastrointestinal pathogen panel multiplex nucleic acid-based assay system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220193	000

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: Room Temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e6ccd67d-f8c1-4e89-b902-b4ec973b559c
Public Version Date: May 09, 2025
Public Version Number: 2
DI Record Publish Date: March 19, 2024

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: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)638-8663
Email: Technical_services@bd.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES