FDA.reportPublic FDA data

SAFE-T-FILL®

Primary DI
50643351000067
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
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981973000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981973000SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEMRam Scientific1998-09-03JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30643351000063PackageGS110In Commercial Distribution
50643351000067PackageGS180In 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
602759672
Device count
50
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

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
10643351000069SAFE-T-FILL®07 705607 70562016-09-15
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

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Primary DI, Brand, Company table
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08586015044854CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
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