FDA.reportPublic FDA data

SAFE-T-FILL®

Primary DI
10643351000069
Brand
SAFE-T-FILL®
Company
Ram Scientific, Inc
Model
07 7056
Catalog number
07 7056
Device description
SAFE-T-FILL® Micro Capillary Blood Collection, 200 µL; Prepared with Dipotassium EDTA; Self-sealing Cap, Purple
Published
2016-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JKATubes, vials, systems, serum separators, blood collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30643351000063PackageGS110Not in Commercial Distribution
50643351000067PackageGS180Not in Commercial Distribution
10643351000069PrimaryGS10
00643351000062Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3064335100006330643351000063
5064335100006750643351000067
1064335100006910643351000069
00643351000062006433510000626433510000620643351000062

GMDN Terms#

Term, Definition table
TermDefinition
Non-evacuated blood collection tube IVD, anticoagulantA non-evacuated glass or plastic tube, sealed with a stopper, containing an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), lithium heparin, sodium citrate]. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., blood lead, whole blood haematology such as complete blood count (CBC), molecular diagnostics, and immunohaematology testing (ABO grouping, Rh typing, antibody screening, plasma coagulation studies and/or and quantitative drug assay determinations)]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume200Microliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight.
Special Storage Condition, Specify00Keep Dry.

Contacts#

Phone, Email table
PhoneEmail
+1(914)969-7900info@ramsci.com

Regulatory Flags#

DUNS number
602759672
Device count
50
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10643351000250SAFE-T-FILL®07 601407 60142016-09-15
10643351000380SAFE-T-FILL®06 050806 05082016-09-15
30643351000254SAFE-T-FILL®07 601407 60142016-09-15
30643351000384SAFE-T-FILL®06 050806 05082016-09-15
10643351000014SAFE-T-FILL®07 601107 60112016-09-15
10643351000021SAFE-T-FILL®07 601307 60132016-09-15
10643351000038SAFE-T-FILL®07 705107 70512016-09-15
10643351000045SAFE-T-FILL®07 705207 70522016-09-15
10643351000052SAFE-T-FILL®07 705307 70532016-09-15
10643351000076SAFE-T-FILL®07 705807 70582016-09-15
10643351000083SAFE-T-FILL®07 610107 61012016-09-15
10643351000090SAFE-T-FILL®07 722007 72202016-09-15
10643351000106SAFE-T-FILL®07 722107 72212016-09-15
10643351000113SAFE-T-FILL®07 725007 72502016-09-15
10643351000120SAFE-T-FILL®07 725107 72512016-09-15
10643351000137SAFE-T-FILL®07 734007 73402016-09-15
10643351000144SAFE-T-FILL®07 712007 71202016-09-15
10643351000151SAFE-T-FILL®07 712107 71212016-09-15
10643351000168SAFE-T-FILL®07 715007 71502016-09-15
10643351000175SAFE-T-FILL®07 715107 71512016-09-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30382903679929BD Vacutainer® SST™ Blood Collection TubeBECTON, DICKINSON AND COMPANYJKA2026-07-20
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10197344216185MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
00850048720343C-QuestLifeOutcomes LLCJKA2026-07-14
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08887629000008BUHNSP TECH PTE LTDJKA2026-05-29
08887629000053BUCANSP TECH PTE LTDJKA2026-05-29
08887629000060BTANSP TECH PTE LTDJKA2026-05-29
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08586015044793CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
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08586015044854CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
10197344019649MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-23