FDA.report

Globe Scientific

Primary DI
00840095602181
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
117713
Device description
Capillary tube, end-to-end, 25uL, 24mm long, K2EDTA
Published
2019-11-27
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
GIOTube, Collection, Capillary Blood

Product Code Classifications

CodeDeviceSpecialtyClass
GIOTube, Collection, Capillary BloodHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840095602181PrimaryGS10
00840095609609Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095602181008400956021818400956021810840095602181
00840095609609008400956096098400956096090840095609609

GMDN Terms

TermDefinition
Capillary blood collection tube IVD, K2EDTAA non-sterile glass or plastic collection tube containing the anticoagulant dipotassium ethylene diamine tetraacetic acid (K2EDTA), intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit). It is typically sealed at one or both ends with a putty-like substance following specimen collection, It is This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
106793995
Device count
1000
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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