← Back to catalogue

Disposable Inflation Device

FDA UDI

Class II (US FDA UDI)

by Micro-Tech (Nanjing) Co., Ltd.

Identity

Trade Name
Disposable Inflation Device FDA UDI
Generic Name
Catheter/overtube balloon inflator, single-use FDA UDI
Device Name
Balloon Inflation Device Maximum pressure is 15atm , the length is 60mm, 5 pcs in the box FDA UDI
Model / Reference
BID-15-60-01 FDA UDI
Description
Balloon Inflation Device Maximum pressure is 15atm , the length is 60mm, 5 pcs in the box FDA UDI

Identifiers

Primary DI / UDI-DI
06932503525015 FDA UDI
FDA Product Code
PTM FDA UDI
FQH FDA UDI
GMDN Term
Catheter/overtube balloon inflator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1650 FDA UDI
880.5475 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Pressure — 15 Atmosphere FDA UDI
Total Volume — 60 Milliliter FDA UDI

Category: Catheter/overtube balloon inflator, single-use

Disposable Inflation Device by Micro-Tech (Nanjing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Catheter/overtube balloon inflator, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Micro-Tech (Nanjing) Co., Ltd.

Sources (1)

  • FDA UDI 8026fca3-b556-4f58-9800-0ecee0ab61db 35 fields · synced May 30, 2026