FDA.reportPublic FDA data

CAPILLARY TUBE, CARE-FILL, BUNDLE OF 50

Primary DI
00809708041137
Brand
CAPILLARY TUBE, CARE-FILL, BUNDLE OF 50
Company
Epocal Inc
Model
AT-0006-00-00
Catalog number
AT-0006-00-00
Published
2016-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092849000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092849000BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZEREpocal, Inc.2010-03-30CEM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00809708041137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00809708041137008097080411378097080411370809708041137

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood transfer tube IVD, heparinA non-sterile glass or plastic capillary blood transfer tube coated internally with the anticoagulant heparin, 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.

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
201179681
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414606095epoc NXS Host11413475162662020-06-18
00630414606460epoc Host211413524114135242020-07-15
00809708016678EPOC HOST MOBILE COMPUTERHH-0003-00-00HH-0003-00-002016-07-05
00809708016685EPOC READERHR-1002-00-00HR-1002-00-002016-07-05
00809708032333EPOC READER, REFURBISHEDHR-1R02-00-00HR-1R02-00-002016-07-05
00809708032340EPOC HOST, REFURBISHEDHH-0R03-00-00HH-0R03-00-002016-07-05
00809708039417EPOC READER, VETERINARY, CEHR-1003-00-002016-07-05
00809708040659EPOC READER, VETERINARY, CE, REFURBISHEDHR-1R03-00-002016-07-05
00809708040666EPOC HOST, VETERINARY, CE, REFURBISHEDHH-0R04-00-002016-07-05
00809708046514EPOC HOST MOBILE COMPUTER, INT'LHH-0003-XU-002016-07-05
00809708046521EPOC HOST, INT'L, REFURBHH-0R03-XU-002016-07-05
00809708049379EPOC HOST, RXHH-0005-00-00HH-0005-00-002016-07-05
00809708049386EPOC HOST, RX, REFURBHH-0R05-00-00HH-0R05-00-002016-07-05
00809708049393EPOC HOST, RX, INT'LHH-0005-XU-00HH-0005-XU-002016-07-05
00809708049409EPOC HOST, RX, INT'L, REFURBHH-0R05-XU-00HH-0R05-XU-002016-07-05
00809708049423EPOC HOST, RX, VET, INT'L, REFURBHH-0R07-00-002016-07-05
00809708051839EPOC HOST, RX, VET, NA, REFURBHH-0R08-00-002016-07-05
00809708052898HOST 2, EPOCHH-1009-00-00HH-1009-00-002016-07-05
00809708052911HOST 2, EPOC, VETERINARYHH-1010-00-002016-07-05
00809708053901HOST 2, EPOC, REFURBISHEDHH-1R09-00-00HH-1R09-00-002016-07-05

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