FDA.reportPublic FDA data

SAFE-T-FILL®

Primary DI
30643351000384
Brand
SAFE-T-FILL®
Company
Ram Scientific, Inc
Model
06 0508
Catalog number
06 0508
Device description
SAFE-T-FILL® MicroHematocrit Capillary Tubes, 50 µL; Plastic, Untreated, Blue Marking
Published
2016-09-15
Public version status
Update
Distribution status
Not 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
GHYHEMATOCRIT, TUBE, RACK, SEALER, HOLDER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GHYHematocrit, Tube, Rack, Sealer, HolderHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30643351000384PackageGS110Not in Commercial Distribution
10643351000380PrimaryGS10
00643351000383Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3064335100038430643351000384
1064335100038010643351000380
00643351000383006433510003836433510003830643351000383

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection tube IVD, no additiveA glass or plastic collection tube containing no additive, intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin). 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 Volume50Microliter

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
100
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
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
10643351000175SAFE-T-FILL®07 715107 71512016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04086000860444CompoSeal Mobilea IIFresenius Kabi AGGHY2022-11-07
00664816002131LW Scientific, Inc.LW SCIENTIFIC, INC.GHY2020-06-30
00664816003671LW Scientific, Inc.LW SCIENTIFIC, INC.GHY2020-01-22
00840095607513Globe ScientificGLOBE SCIENTIFIC INC.GHY2019-11-26
0086000102402975mm Self-Sealing Capillary TubesDRUMMOND SCIENTIFIC COMPANYGHY2019-08-01
0086000102403675mm Plastic-crit PlainDRUMMOND SCIENTIFIC COMPANYGHY2019-07-19
0086000102404375mm Plastic-crit HeparinizedDRUMMOND SCIENTIFIC COMPANYGHY2019-07-19
0086000102400575mm Hemato-clad PlainDRUMMOND SCIENTIFIC COMPANYGHY2019-05-01
0086000102401275mm Hemato-clad HeparinizedDRUMMOND SCIENTIFIC COMPANYGHY2019-05-01
00817517020014Marketlab IncMARKETLAB INC.GHY2018-11-16
00817517020021Marketlab IncMARKETLAB INC.GHY2018-11-16
00817517020038Marketlab IncMARKETLAB INC.GHY2018-11-16
00817517020045Marketlab IncMARKETLAB INC.GHY2018-11-16
04050674084833Hematocrit capillariesAndreas Hettich GmbHGHY2016-09-24
04050674019262Sealing Putty for hematocrit capillariesAndreas Hettich GmbHGHY2016-09-24
04050674019279Hematocrit capillariesAndreas Hettich GmbH & Co. KGGHY2016-09-24
10643351000373SAFE-T-FILL®Ram Scientific, IncGHY2016-09-15
10643351000380SAFE-T-FILL®Ram Scientific, IncGHY2016-09-15
10643351000397SAFE-T-FILL®Ram Scientific, IncGHY2016-09-15
30643351000377SAFE-T-FILL®Ram Scientific, IncGHY2016-09-15
30643351000391SAFE-T-FILL®Ram Scientific, IncGHY2016-09-15