FDA.reportPublic FDA data

SAFE CLINIT. D957P-70-100X1

Primary DI
55700699428924
Brand
SAFE CLINIT. D957P-70-100X1
Company
Radiometer Medical ApS
Model
942-892
Catalog number
942-892
Device description
D957P-70-100x1 safeCLINITUBES Blood Sampler Multipack with heparinized plastic capillaries and accessories. 100 µL, 1 vial of 250 units
Published
2022-12-05
Public version status
New
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
05700699428929PrimaryGS10
55700699428924Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700699428929057006994289295700699428929
5570069942892455700699428924

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection tube IVD, electrolyte-balanced heparinA non-sterile glass or plastic collection tube containing electrolyte-balanced heparin (anticoagulant), intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin, plasma chemistry determinations). 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 Temperature2 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700699428929SAFE CLINIT. D957P-70-100X1942-892942-8922022-12-05
05700699428936SAFE CLINIT. D957P-70-125X1942-893942-8932022-12-05
05700699428981SAFE CLINITUBES D957P-70-70X1942-898942-8982024-07-01
05700699429698safeClinitubes D957P-70-45942-969942-9692022-12-05
05700699440174QUALICHECK 5+, LEVEL 1944-017944-0172022-12-05
05700699440198QUALICHECK 5+, LEVEL 3944-019944-0192022-12-05
05700699440822AUTOCHECK 3+, LEVEL 1, S7335944-082944-0822022-12-05
05700699440839AUTOCHECK 3+, LEVEL 2, S7345944-083944-0832022-12-05
05700699440846AUTOCHECK 3+, LEVEL 3, S7355944-084944-0842022-12-05
05700699440853AUTOCHECK 3+, LEVEL 4, S7365944-085944-0852022-12-05
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05700699058713Membraning kit for tc sensor 84905-871905-8712016-09-01
05700699060266ABL90 FLEX, Clot catcher906-026906-0262016-09-01
05700699420589Membrane for E1001 electrode942-058942-0582016-09-01
05700699420633Membrane for E788 electrode942-063942-0632016-09-01
05700699420640Membrane for E799 electrode942-064942-0642016-09-01
05700699420664Membrane for E7077 electrode942-066942-0662016-09-01
05700699439062S5362 REF 943-906943-906943-9062018-09-21
05700699440211Calibration Solution944-021944-0212016-09-01
05700699441263Cleaning Solution with additive S8375 REF 944-126944-126944-1262018-09-21

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