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
04038917127653Microvette® CB 200 NC18.1325.10018.1325.1002022-11-30
04038917418867Adapter sleeve14.121614.12162024-04-26
04038917988278Archiving Cap with filter65.647.32065.647.3202024-02-20
04038917113861UriSet 24 without acid77.578.01077.578.0102022-11-30
04038917927055Sediplus® S 2000 NX90.109290.10922022-11-30
04038917132176S-Monovette®03.1628.10003.1628.1002016-09-16
04038917431705S-Monovette®04.195204.19522019-09-30
04038917522793S-Monovette®04.1954.10004.1954.1002019-09-24
04038917522830S-Monovette®04.1952.10004.1952.1002019-09-24
04038917522878S-Monovette®04.1954.20004.1954.2002019-09-24
04038917522953S-Monovette®04.1953.20004.1953.2002019-09-24
04038917522991S-Monovette®04.1952.20004.1952.2002019-09-24
04038917523318S-Monovette®04.1953.10004.1953.1002019-09-21
04038917240345Safety-Multifly®-Needle85.1638.93585.1638.9352016-09-16
04038917281812Micro-Needle85.92385.9232016-09-16
04038917281843Micro-Needle85.92585.9252016-09-16
04038917315517Micro-Needle85.92185.9212016-09-16
04038917423410Safety-Multifly® 23G w.holder85.1640.93585.1640.9352024-02-20
04038917423892Safety-Multifly®-Needle85.1638.20185.1638.2012019-12-13
04038917423724Multifly®-Needle85.163885.16382019-10-06

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