FDA.report

EXEL 5ML CLEAR HLDR, Non-Sterile

Primary DI
10020221265313
Brand
EXEL 5ML CLEAR HLDR, Non-Sterile
Company
Exel International
Model
26531
Catalog number
26531
Device description
EXEL 5ML CLEAR HLDR, Non-Sterile 1,000PCS/DOUBLE BAG PER CASE
Published
2023-03-16
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

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
10020221265313PackageGS11000In Commercial Distribution
20020221265310PackageGS11In Commercial Distribution
00020221265316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1002022126531310020221265313
2002022126531020020221265310
00020221265316000202212653160202212653160020221265316

GMDN Terms

TermDefinition
Blood collection tube holder/needleA sterile, hand-held cylindrical device with a pre-attached needle designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor with a pre-attached blood collection needle at one end and into which the blood collection tube is inserted at the other end; this also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
180572216
Device count
1
DM exempt
false
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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