FDA.report

BD Intraosseous Vascular Access System

Primary DI
10801741201070
Brand
BD Intraosseous Vascular Access System
Company
Bard Access Systems, Inc.
Model
D001001R
Catalog number
D001001R
Device description
BD Intraosseous Powered Driver (Refurb)
Published
2019-11-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FMINeedle, hypodermic, single lumen

Product Code Classifications

CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741201070PackageGS11In Commercial Distribution
00801741201073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174120107010801741201070
00801741201073008017412010738017412010730801741201073

GMDN Terms

TermDefinition
Intraosseous-access handpiece, infusion, electricA hand-held, battery-powered device designed to be used with a separate rotary cutting needle (endpiece) to access bone marrow for intraosseous infusion of fluids and medication. It is used as an alternative to intravenous (IV) access typically when IV access is not feasible. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)545-0890medical.services@crbard.com

Regulatory Flags

DUNS number
044611812
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00801741045141Niagara Slim-Cath catheter543412054341202015-11-20
00801741045158Niagara Slim-Cath catheter543415054341502015-11-06
10801741231275CentroVena One1K0R72161K0R72162026-01-23
10801741231282CentroVena One1K0R72201K0R72202026-01-23
10801741231305CentroVena One1K0R73161K0R73162026-01-23
10801741231312CentroVena One1K0R73201K0R73202026-01-23
10801741231329CentroVena One1K0R73301K0R73302026-01-23
10801741231336CentroVena One1MB0R72161MB0R72162026-01-23

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