FDA.reportPublic FDA data

Medichoice

Primary DI
20885632147248
Brand
Medichoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
BC1005
Device description
Kit Blood Culture Peripheral No Gloves Or Culture Bottles
Published
2016-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OFMPhlebotomy blood collection kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFMPhlebotomy Blood Collection KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885632147248PackageGS120In Commercial Distribution
10885632147241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088563214724820885632147248
1088563214724110885632147241

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00
Special Storage Condition, Specify00Avoid freezing and excessive heat

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007941230
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632434266Halyard563482026-05-22
10885632434303Halyard563522026-05-22
10885632468490Halyard614862026-05-22
10885632468506Halyard614872026-05-22
10885632468513Halyard614882026-05-22
10885632468520Halyard614892026-05-22
10885632509032Halyard620732026-05-22
10885632509049Halyard620742026-05-22
10885632509056Halyard620752026-05-22
10885632509063Halyard620762026-05-22
10885632510199Halyard620772026-05-22
10885632521751SurgiTrackSM450130D17D2026-05-22
10885632517105SurgiTrackSM4500410F102026-03-23
10885632516429SurgiTrackSM4500309F242026-03-17
30885632495469HalyardIDSG10012026-03-13
20885632495851HalyardIDSG10022026-03-13
20885632495868HalyardIDSG10032026-03-13
20885632495875HalyardIDSG10042026-03-13
20885632495882HalyardIDSG10052026-03-13
20885632496742HalyardIDSG10062026-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956234909CARDINAL HEALTHCardinal Health 200, LLCOFM2026-01-15
20809160505349Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-12-02
50198956207637CARDINAL HEALTHCardinal Health 200, LLCOFM2025-09-29
50198956062694CARDINAL HEALTHCardinal Health 200, LLCOFM2025-05-29
20809160466602Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-05-08
20809160460716Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-03-18
20809160460204Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-03-12
00860009842274Straight Needle Phlebotomy KitLabcorp Genetics IncOFM2025-02-13
00860009842281Butterfly Needle Phlebotomy KitLabcorp Genetics IncOFM2025-02-13
20809160432508Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2024-08-16
20809160424428Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2024-04-30
20194717117824Regard™ROI CPS, LLCOFM2023-09-29
20194717117831Regard™ROI CPS, LLCOFM2023-09-29
20809160403324Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2023-06-23
00852714003187Aurix XLNuo Therapeutics, Inc.OFM2023-03-27
00852937003018INNOVATE MEDICALINNOVATE MEDICAL, LLCOFM2022-11-14
10852937003022INNOVATE MEDICALINNOVATE MEDICAL, LLCOFM2022-11-14
50195594068224CARDINAL HEALTHCardinal Health 200, LLCOFM2021-11-05
50195594383891CARDINAL HEALTHCardinal Health 200, LLCOFM2021-10-19
20809160359270Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2021-09-13
20809160351861Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2021-06-04
50195594062864CARDINAL HEALTHCardinal Health 200, LLCOFM2021-05-13
50195594043528CARDINAL HEALTHCardinal Health 200, LLCOFM2021-05-03
10193489867008Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFM2021-04-18
50195594969729CARDINAL HEALTHCardinal Health 200, LLCOFM2021-04-07
50195594971517CARDINAL HEALTHCardinal Health 200, LLCOFM2021-04-07
50195594955715CARDINAL HEALTHCardinal Health 200, LLCOFM2021-03-31
50888439973424CARDINAL HEALTHCardinal Health 200, LLCOFM2021-01-10
20809160342036Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2021-01-06
20809160296360Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2020-12-02