FDA.reportPublic FDA data

N/A

Primary DI
00817827022692
Brand
N/A
Company
CHARTER MEDICAL, LTD.
Model
03-BDP-60
Catalog number
03-BDP-60
Device description
Neonatal/Pediatric Syringe Set 150µ Filter, 60cc Syringe, 150mL bag
Published
2016-09-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000685000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000685000CHARTER MEDICAL NEONATAL SYRINGE SETCharter Medical, Ltd.2000-08-15BRZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817827022692PackageGS118In Commercial Distribution
00817827022197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817827022692008178270226928178270226920817827022692
00817827022197008178270221978178270221970817827022197

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfusion setA sterile, intravascular administration set used to administer blood from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(866) 458-3116CML_CustomerService@CharterMedical.com

Regulatory Flags#

DUNS number
029062325
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00817827023019Cell FreezeCF-250CF-2502021-08-23
00817827023026Cell FreezeCF-250-3LCF-250-3L2021-08-23
00817827023033Cell FreezeCF-500CF-5002021-08-23
00817827023040Cell FreezeCF-500-3LCF-500-3L2021-08-23
00817827023057Cell FreezeCF-50CF-502021-08-23
00817827023064Cell FreezeCF-750CF-7502021-08-23
00817827023088Cell FreezeCML-75LNCML-75LN2021-08-23
00817827025044N/AC600C6002016-09-24
00817827025051N/AC605C6052016-09-24
00817827025129N/AT3006T30062016-09-24
00817827025136N/AT3101T31012016-09-24
00817827025143N/AT3104T31042016-09-24
00817827025150N/AT3106T31062016-09-24
00817827025167N/AT3106X2T3106X22016-09-24
00817827025174N/AT3107T31072016-09-24
00817827025181N/AT3108T31082016-09-24
00817827025198N/AT3109T31092016-09-24
00817827025204N/AT3110T31102016-09-24
00817827025211N/AT3194T31942016-09-24
00817827025228N/AT3400T34002016-09-24

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Primary DI, Brand, Company table
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