FDA.reportPublic FDA data

SAFE-T-FILL®

Primary DI
30643351000261
Brand
SAFE-T-FILL®
Company
RAM SCIENTIFIC, INC
Model
06 0185
Catalog number
06 0185
Device description
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 µL; Prepared with Balanced Heparin
Published
2022-10-01
Public version status
New
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
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
30643351000261PackageGS14In Commercial Distribution
10643351000267PrimaryGS10
00643351000260Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3064335100026130643351000261
1064335100026710643351000267
00643351000260006433510002606433510002600643351000260

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume115Microliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
602759672
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
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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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
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