FDA.reportPublic FDA data

BD Syringe NRFit™ Slip

Primary DI
50382904000511
Brand
BD Syringe NRFit™ Slip
Company
BECTON, DICKINSON AND COMPANY
Model
400051
Catalog number
400051
Device description
BD® 5mL Syringe NRFit™ Slip
Published
2022-03-21
Public version status
New
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
QEHPiston Syringe with neuraxial connector – epidural, peripheral, and/or indirect cerebral spinal fluid contact

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEHPiston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact General Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192538000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192538000BD Syringe NRFit Lok and BD Syringe NRFit SlipBecton, Dickinson and Company2020-09-04QEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904000517PackageGS1125In Commercial Distribution
50382904000511PackageGS14In Commercial Distribution
00382904000516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290400051730382904000517
5038290400051150382904000511
00382904000516003829040005163829040005160382904000516

GMDN Terms#

Term, Definition table
TermDefinition
Neuraxial syringeA sterile device consisting of a calibrated barrel (cylinder) with plunger intended for neuraxial applications (to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes). At the distal end of the barrel is a male connector, designed according to ISO 80369-6 (often referred to as an NRFit connection), intended specifically for connection to neuraxial devices (e.g., needles, catheters, tubing) with the appropriate NRFit connection. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile, handle with care
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Room Temperature

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001292192
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
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
00382905167065BD Intelliport5167065167062020-09-30
50382905167015BD Intelliport5167015167012020-09-30
00382905167508BD Intelliport5167505167502020-09-30
00382905168031BD Intelliport System5168035168032024-06-07
00382905168000BD Intelliport System5168005168002024-06-07
00382905167041BD Intelliport5167045167042020-09-30
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer Module4453504453502026-06-02
30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder3686543686542024-03-25
00382904003739BD Whitacre Spinal4003734003732023-09-02
00382904003821BD Whitacre Spinal4003824003822023-09-02
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02
00885403522270Swan-Ganz131F7P2026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
46971564464343CAINAJiangsu Caina Medical Co.,LtdQEH2026-04-14
B212576031Female NRFit Tip CapINTERNATIONAL MEDICAL INDUSTRIES INC.QEH2026-01-23
B212576032Female NRFit Tip CapINTERNATIONAL MEDICAL INDUSTRIES INC.QEH2026-01-23
00382904000509BD Syringe NRFit™ LokBECTON, DICKINSON AND COMPANYQEH2022-03-21
00382904000516BD Syringe NRFit™ SlipBECTON, DICKINSON AND COMPANYQEH2022-03-21
00382904001728BD Syringe NRFit™ SlipBECTON, DICKINSON AND COMPANYQEH2022-03-21
00382904001735BD Syringe NRFit™ LokBECTON, DICKINSON AND COMPANYQEH2022-03-21
00382904001742BD Syringe NRFit™ LokBECTON, DICKINSON AND COMPANYQEH2022-03-21
00382904001759BD Syringe NRFit™ SlipBECTON, DICKINSON AND COMPANYQEH2022-03-21
00382904001827BD Syringe NRFit™ LokBECTON, DICKINSON AND COMPANYQEH2022-03-21
00382904001834BD Syringe NRFit™ LokBECTON, DICKINSON AND COMPANYQEH2022-03-21
50382904000504BD Syringe NRFit™ LokBECTON, DICKINSON AND COMPANYQEH2022-03-21
50382904001723BD Syringe NRFit™ SlipBECTON, DICKINSON AND COMPANYQEH2022-03-21
50382904001730BD Syringe NRFit™ LokBECTON, DICKINSON AND COMPANYQEH2022-03-21
30382904001743BD Syringe NRFit™ LokBECTON, DICKINSON AND COMPANYQEH2022-03-21
50382904001754BD Syringe NRFit™ SlipBECTON, DICKINSON AND COMPANYQEH2022-03-21
50382904001822BD Syringe NRFit™ LokBECTON, DICKINSON AND COMPANYQEH2022-03-21
50382904001839BD Syringe NRFit™ LokBECTON, DICKINSON AND COMPANYQEH2022-03-21