FDA.reportPublic FDA data

BD Syringe NRFit™ Lok

Primary DI
50382904000504
Brand
BD Syringe NRFit™ Lok
Company
BECTON, DICKINSON AND COMPANY
Model
400050
Catalog number
400050
Device description
BD® 3mL Syringe NRFit™ Lok
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
30382904000500PackageGS1200In Commercial Distribution
50382904000504PackageGS14In Commercial Distribution
00382904000509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290400050030382904000500
5038290400050450382904000504
00382904000509003829040005093829040005090382904000509

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 Volume3Milliliter

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
00382902780519BD Macro-Vue™ Card Test Rotator2780512780512016-05-19
00885403522324Swan-Ganz151F7151F72026-07-31
00885403523581VAMP48VMP10648VMP1062026-07-31
00885403523598VAMP48VMP12048VMP1202026-07-31
00885403523734VAMP48VMP18448VMP1842026-07-31
00885403524281TruWave, VAMP PlusPXVP1087PXVP10872026-07-31
00885403524694TruWave, VAMP PlusPXVP0550PXVP05502026-07-31
00885403524922TruWavePX266CPX266C2026-07-31
00885403525066TruWave, VAMPPXAVMPPXAVMP2026-07-31
00885403525547TruWave, VAMPPXAVMP3PXAVMP32026-07-31
00885403525608TruWave, VAMPPXVMP172AT3PXVMP172AT32026-07-31
00885403525646TruWave, VAMP PlusPXVP1071PXVP10712026-07-31
00885403529644Acumen IQ CuffAIQCLAIQCL2026-07-31
00885403529651Acumen IQ CuffAIQCMAIQCM2026-07-31
00885403530404Fogarty120404F120404F2026-07-31
00885403530411Fogarty120602F120602F2026-07-31
00885403530428Fogarty120803F120803F2026-07-31
00885403530442Fogarty120804F120804F2026-07-31
00885403530466Fogarty120805F120805F2026-07-31
00885403530565Fogarty12TLW805F3512TLW805F352026-07-31

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
50382904000511BD Syringe NRFit™ SlipBECTON, 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