← Back to catalogue

Gri-Bag

FDA UDI

Class II (US FDA UDI)

by Laboratorios Grifols Sa

Identity

Trade Name
GRI-BAG FDA UDI
Generic Name
Compounding transfer set FDA UDI
Device Name
GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filter. It is supplied sterile in sealed peel-pack pouches and is available in volume capacities of 100 ml, 250 ml, 500 ml and 1000 ml. The GRI-BAG models have a twist-off valve output connector whereas the GRIBAG AP models have a conus vial output connector. FDA UDI
Model / Reference
1000 FDA UDI
Description
GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filter. It is supplied sterile in sealed peel-pack pouches and is available in volume capacities of 100 ml, 250 ml, 500 ml and 1000 ml. The GRI-BAG models have a twist-off valve output connector whereas the GRIBAG AP models have a conus vial output connector. FDA UDI

Identifiers

Primary DI / UDI-DI
08426314575683 FDA UDI
510(k) Number
K033916 FDA UDI
FDA Product Code
KPE FDA UDI
FPB FDA UDI
NEP FDA UDI
GMDN Term
Compounding transfer set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5025 FDA UDI
880.5440 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Gri-Bag by Laboratorios Grifols Sa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K033916 also covers:

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
Laboratorios Grifols Sa

Sources (1)

  • FDA UDI c9a33dd6-8166-455c-a367-83c54e1f90dc 35 fields · synced May 30, 2026