FDA.report

Design Options®

Primary DI
04046964526640
Brand
Design Options®
Company
B. BRAUN MEDICAL INC.
Model
570244
Catalog number
570244
Device description
PNB/Support Tray
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CAZAnesthesia conduction kit

Product Code Classifications

CodeDeviceSpecialtyClass
CAZAnesthesia Conduction KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964526640PrimaryGS10
04046964526633Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964526640040469645266404046964526640
04046964526633040469645266334046964526633

GMDN Terms

TermDefinition
Peripheral anaesthesia catheter set, non-medicatedA collection of devices intended for the continuous-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and an anaesthesia catheter usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature1 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)227-2862BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags

DUNS number
002397347
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
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

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