FDA.reportPublic FDA data

SAFECAP®

Primary DI
15060586450011
Brand
SAFECAP®
Company
SAFE-TEC CLINICAL PRODUCTS LLC
Model
H75-2000M
Catalog number
H75-2000M
Published
2021-01-27
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
05060586450014PrimaryGS10
15060586450011Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060586450014050605864500145060586450014
1506058645001115060586450011

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection tube IVD, lithium heparinA non-sterile glass or plastic collection tube containing the anticoagulant lithium heparin, 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(215)364-5582tring@safe-tecllc.com

Regulatory Flags#

DUNS number
361287816
Device count
2000
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
true
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
05060586450014SAFECAP®H75-2000MH75-2000M2021-01-27
05060586450021SAFECAP®P75-2000MP75-2000M2021-01-27
05060586450038SAFECAP®R60-2000MR60-2000M2021-01-27
05060586450052MICROSAFE®1010S-501010S-502021-01-27
05060586450069MICROSAFE®1015-101015-102021-01-27
05060586450076MICROSAFE®1015-501015-502021-01-27
05060586450083MICROSAFE®1020-501020-502021-01-27
05060586450090MICROSAFE®1030-501030-502021-01-27
05060586450106MICROSAFE®1040-501040-502021-01-27
05060586450113MICROSAFE®1050-501050-502021-01-27
05060586450120MICROSAFE®1075-501075-502021-01-27
15060586450028SAFECAP®P75-2000MP75-2000M2021-01-27
15060586450035SAFECAP®R60-2000MR60-2000M2021-01-27
15060586450059MICROSAFE®1010S-501010S-502021-01-27
15060586450066MICROSAFE®1015-101015-102021-01-27
15060586450073MICROSAFE®1015-501015-502021-01-27
15060586450080MICROSAFE®1020-501020-502021-01-27
15060586450097MICROSAFE®1030-501030-502021-01-27
15060586450103MICROSAFE®1040-501040-502021-01-27
15060586450110MICROSAFE®1050-501050-502021-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850059420515SAFECAPDRUMMOND SCIENTIFIC COMPANYGIO2026-05-18
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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
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16974621793294LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-09
06974621793303LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
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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
00860001024067MICROSAFEDRUMMOND SCIENTIFIC COMPANYGIO2025-05-06