FDA.report

Marketlab Inc

Primary DI
00817517020274
Brand
Marketlab Inc
Company
MARKETLAB INC.
Model
34669
Catalog number
34669
Device description
BD Vacutainer®,Sodium Fluoride,Gray 13x75mm,2mL PK100
Published
2018-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JKATubes, vials, systems, serum separators, blood collection

Product Code Classifications

CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817517020274PrimaryGS10
00817517021097Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817517020274008175170202748175170202740817517020274
00817517021097008175170210978175170210970817517021097

GMDN Terms

TermDefinition
Capillary blood transfer tube IVD, sodium fluorideA non-sterile glass or plastic capillary blood transfer tube coated internally with the antiglycolytic agent sodium fluoride, and intended to be attached to a non-evacuated blood collection tube to assist with the transfer of blood drops from the blood collection site into the collection tube using a capillary action. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866) 237-3722service@marketlabinc.com

Regulatory Flags

DUNS number
848917027
Device count
100
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

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