FDA.reportPublic FDA data

SAFE CLINIT. D941P-240-85X1

Primary DI
05700699428905
Brand
SAFE CLINIT. D941P-240-85X1
Company
Radiometer Medical ApS
Model
942-890
Catalog number
942-890
Device description
D941P-240-85x1 safeCLINITUBES Blood Sampler Multipack with heparinized plastic capillaries and accessories. 85 µL, 1 vial of 250 units
Published
2022-12-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GIOTUBE, COLLECTION, CAPILLARY BLOOD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIOTube, Collection, Capillary BloodHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700699428905PrimaryGS10
55700699428900Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700699428905057006994289055700699428905
5570069942890055700699428900

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection tube IVD, sodium heparinA non-sterile glass or plastic collection tube containing the anticoagulant sodium heparin, intended to be used for the collection preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin). It is typically sealed at one or both ends with a putty-like substance following specimen collection. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Sensitive to light. Store in a dark place
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+4538273827radiometer@radiometer.dk

Regulatory Flags#

DUNS number
308667539
Device count
250
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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05700699428936SAFE CLINIT. D957P-70-125X1942-893942-8932022-12-05
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05700699566157safePICO70956-615956-6152016-09-01
05700699566164safePICO70956-616956-6162016-09-01
05700699566232safePICO956-623956-6232016-09-01
05700699566249safePICO70956-624956-6242016-09-01
05700699056894TC contact liquid905-689905-6892016-09-01
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