FDA.report

ARROW

Primary DI
20801902202073
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN922615
Catalog number
MTO-03000-VM
Device description
Single Shot Epidural Anesthesia Kit (No Catheter Included)
Published
2021-08-02
Public version status
New
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
20801902202073PackageGS110In Commercial Distribution
10801902202076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080190220207320801902202073
1080190220207610801902202076

GMDN Terms

TermDefinition
Epidural anaesthesia set, medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal anaesthesia. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Avoid freezing.
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

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30841156103983SUPERCROSS530253022026-03-23
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20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

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