FDA.reportPublic FDA data

Twist cap for Microvette®

Primary DI
04038917418263
Brand
Twist cap for Microvette®
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
65.1244.028
Catalog number
65.1244.028
Published
2022-11-30
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
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
04038917418263PrimaryGS10
04038917418270Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917418263040389174182634038917418263
04038917418270040389174182704038917418270

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood transfer tube IVD, clot activatorA non-sterile glass or plastic capillary blood transfer tube coated internally with a clot activator, and intended to be attached to a non-evacuated blood collection tube to assist with the transfer of blood drops from the blood collection site into the collection tube using a capillary action. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)257-5101customerservice.us@sarstedt.com

Regulatory Flags#

DUNS number
388000270
Device count
1000
DM exempt
true
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
04038917226431Sediplus® S 200, 12 V DC90.189.90090.189.9002022-11-30
04038917082518Screw cap for 100ml cup76.56476.5642022-11-30
04038917159647Srew cap Tobe 10 ml with Stabilur tablet51.1543.00451.1543.0042024-11-18
0403891739990610ml TBE 100x16 PP RED SCW CAP51.9923.83051.9923.8302023-01-18
04066916018412urine cup 76x 6075.562.00275.562.0022025-01-14
04038917530552S-Monovette®-Needle 23Gx1"85.144285.14422025-10-22
04038917086318Urine receptacle 500ml75.135675.13562025-05-19
04038917927048Sediplus® S 2000 NX90.109290.10922026-07-22
04038917124614TUBE SEGMENT OPENER ASM TB 75/12 PS95.1000.47695.1000.4762026-07-21
04038917124935ESR RACK N/BACK PANEL90.1060.06290.1060.0622026-07-21
04038917390835TUBE SEGMENT OPENER ASM TB 75/ 12 PS CB95.1000.47795.1000.4772026-07-21
04038917581882Salivette®51.1534.10051.1534.1002026-07-21
04066916053802Tube 3.5ml, 92x13 (round), PP62.617.00162.617.0012026-07-21
04066916055837Screw cap, pastel-green65.716.04565.716.0452026-07-21
04066916055998Screw cap, pastel-orange65.716.04665.716.0462026-07-21
04066916056049Screw cap, pastel-violet65.716.04865.716.0482026-07-21
04066916056148Screw cap, pastel-yellow65.716.04265.716.0422026-07-21
04066916056407Screw cap, pastel-blue65.716.04165.716.0412026-07-21
04066916057831SafeSeal tube 0.5ml72.704.05072.704.0502026-07-21
04066916057879SafeSeal tube 0.5ml, brown72.704.05172.704.0512026-07-21

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