FDA.reportPublic FDA data

Capillary Caps

Primary DI
00630414115801
Brand
Capillary Caps
Company
Siemens Healthcare Diagnostics Inc.
Model
10311054
Catalog number
478605
Device description
100 capillary caps. An in vitro diagnostics medical device for use with Siemens Healthcare Diagnostics 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

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
00630414115801PrimaryGS10
00630414009292Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414115801006304141158016304141158010630414115801
00630414009292006304140092926304140092920630414009292

GMDN Terms#

Term, Definition table
TermDefinition
Microcapillary blood collection tube IVD, no additiveA non-sterile glass or plastic microcollection tube, typically sealed at one or both ends with a putty-like substance following specimen collection, containing no additive. It is intended to be used for the collection, and preservation and/or transport, of capillary blood for analysis or other investigation (e.g., neonatal bilirubin). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
064608573
Device count
100
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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