FDA.reportPublic FDA data

BD Pre-Warm Heater

Primary DI
00382904429508
Brand
BD Pre-Warm Heater
Company
BECTON, DICKINSON AND COMPANY
Model
442950
Catalog number
442950
Device description
BD Pre-Warm Heater
Published
2016-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOIreal time Nucleic acid amplification system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140447000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140447000BD VIPER LT SYSTEMBecton, Dickinson and Company2014-05-20OOI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904429508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904429508003829044295083829044295080382904429508

GMDN Terms#

Term, Definition table
TermDefinition
Test tube heaterAn 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth54.4Centimeter
Height13Centimeter
Width29.7Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius33 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
Device count
1
Serial number
true

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00885403530565Fogarty12TLW805F3512TLW805F352026-07-31

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