FDA.report

Capillary Caps

Primary DI
00630414115238
Brand
Capillary Caps
Company
Siemens Healthcare Diagnostics Inc.
Model
10328655
Catalog number
478527
Device description
Multicap® and Multicap-S 2.34mm OD blood collection capillary tubes
Published
2016-09-24
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

Related Records

Contact Domains

Product Codes

CodeName
GIOTUBE, COLLECTION, CAPILLARY BLOOD

Product Code Classifications

CodeDeviceSpecialtyClass
GIOTube, Collection, Capillary BloodHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00630414115238PrimaryGS10
00630414010502Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414115238006304141152386304141152380630414115238
00630414010502006304140105026304140105020630414010502

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags

DUNS number
064608573
Device count
200
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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