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Asp Medical

FDA UDI

Class I (US FDA UDI)

by Asp Global, LLC

Identity

Trade Name
ASP MEDICAL FDA UDI
Generic Name
Intravenous pressure infusor, manual, single-use FDA UDI
Device Name
BAG, PRESSURE INFUSER, 1000ML, MESH BACK, NON-MAGNETIC/MRI CONDITIONAL, 160 mm (W) x 418 mm (H), 5EA/BX, 5BX/CS (25EA/CS) FDA UDI
Model / Reference
IAMRC02 FDA UDI
Description
BAG, PRESSURE INFUSER, 1000ML, MESH BACK, NON-MAGNETIC/MRI CONDITIONAL, 160 mm (W) x 418 mm (H), 5EA/BX, 5BX/CS (25EA/CS) FDA UDI

Identifiers

Primary DI / UDI-DI
00840216108028 FDA UDI
FDA Product Code
KZD FDA UDI
GMDN Term
Intravenous pressure infusor, manual, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5420 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Intravenous pressure infusor, manual, single-use

Asp Medical by Asp Global, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravenous pressure infusor, manual, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Asp Global, LLC

Sources (1)

  • FDA UDI 0117e118-fb53-4311-ae48-41530c3c483f 33 fields · synced May 30, 2026