FDA.report

Urine container 3.0 l

Primary DI
04038917266239
Brand
Urine container 3.0 l
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
77.575.001
Catalog number
77.575.001
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NNKCONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038917266222PrimaryGS10
04038917266239Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038917266222040389172662224038917266222
04038917266239040389172662394038917266239

GMDN Terms

TermDefinition
Non-evacuated urine specimen container IVD, no additiveA covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other investigation. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)257-5101customerservice.us@sarstedt.com

Regulatory Flags

DUNS number
388000270
Device count
30
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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