FDA.reportPublic FDA data

RL 1200 Waste Bottle Kit

Primary DI
00630414515144
Brand
RL 1200 Waste Bottle Kit
Company
Siemens Healthcare Diagnostics Inc.
Model
10324896
Catalog number
6641057
Device description
Waste Bottle Kit. An in vitro diagnostics device for use on the RAPIDLab® 1200 series analyzer.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K934907000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K934907000860 MEASURMENT SYSTEMCiba Corning Diagnostics Corp.1994-01-03CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414515144PrimaryGS10
00630414010489Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414515144006304145151446304145151440630414515144
00630414010489006304140104896304140104890630414010489

GMDN Terms#

Term, Definition table
TermDefinition
Contaminated waste receptacleA device designed as a container to allow the safe deposit, collection and storage of contaminated and/or otherwise hazardous biological materials; this can be waste products containing or having been in contact with, e.g., human blood, sputum, urine, faeces; it is not intended for in vitro diagnostic purposes. This container consists of a metal and/or hard plastic structure and is typically lined with a disposable liner. It will usually have a lid that self-closes and will be identified with a contaminated material symbol on its labelling. The contents will be sent to disposal usually by incineration. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
4

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Primary DI, Brand, Model table
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00630414611075Atellica CH Crea311537215115372152026-05-08
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00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16

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