FDA.reportPublic FDA data

SAFE CLINITUBES D957P-70-70X1

Primary DI
05700699428981
Brand
SAFE CLINITUBES D957P-70-70X1
Company
Radiometer Medical ApS
Model
942-898
Catalog number
942-898
Device description
D957P-70-70x1 safeCLINITUBES Blood Sampler Multipack with heparinized plastic capillaries and accessories. 70 µL, 1 vial of 250 units. For ABL77
Published
2024-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
05700699428981PrimaryGS10
55700699428986Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700699428981057006994289815700699428981
5570069942898655700699428986

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

Contacts#

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

Regulatory Flags#

DUNS number
308667539
Device count
250
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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
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
05700699058027Disposable Waste Container D513 REF 905-802905-802905-8022018-09-21
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
05700699441287Calibration Solution 1944-128944-1282016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850059420515SAFECAPDRUMMOND SCIENTIFIC COMPANYGIO2026-05-18
00850059420492MICROSAFEDRUMMOND SCIENTIFIC COMPANYGIO2026-04-17
00850059420508MICROSAFEDRUMMOND SCIENTIFIC COMPANYGIO2026-04-17
00857182006784UltraFlo-CInnovative Medical Technologies, Inc.GIO2025-12-30
00857182006807UltraFlo-CInnovative Medical Technologies, Inc.GIO2025-12-30
00848530108113DIATUBE002SUNSET HEALTHCARE SOLUTIONS, INC.GIO2025-12-23
10848530108110DIATUBE002SUNSET HEALTHCARE SOLUTIONS, INC.GIO2025-12-23
00381934774015PTS Diagnostics Capillary TubesPOLYMER TECHNOLOGY SYSTEMS, INC.GIO2025-06-16
10381934774012PTS Diagnostics Capillary TubesPOLYMER TECHNOLOGY SYSTEMS, INC.GIO2025-06-16
06974621793259LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
06974621793266LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
06974621793273LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
06974621793280LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
06974621793297LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
16974621793256LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
16974621793263LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
16974621793270LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
16974621793287LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
16974621793294LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
06974621793303LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
06974621793310LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
06974621793327LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
16974621793300LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
16974621793317LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
16974621793324LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
06974621793334LT Tube for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
06974621793341LT Tube for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
06974621793358LT Tube for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
06974621793365LT Tube for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
06974621793372LT Tube for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06