KSR · Container, Empty, For Collection & Processing Of Blood & Blood Components
Hematology · 21 CFR 864.9100 · Class 2
Overview
| Product Code | KSR |
|---|---|
| Device Name | Container, Empty, For Collection & Processing Of Blood & Blood Components |
| Regulation | 21 CFR 864.9100 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
An empty container for the collection and processing of blood and blood components is a device intended for medical purposes that is an empty plastic bag or plastic or glass bottle used to collect, store, or transfer blood and blood components for further processing.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K032827 | KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 | Tyco Healthcare | Dec 8, 2003 | SESE |
| K020753 | DEROYAL SURGICAL, UMBILICUP | Deroyal | Jun 13, 2002 | SESE |
| K810897 | ALPHA PLASTIC PLASMA BOTTLE | Alpha Therapeutic Corp. | Sep 23, 1981 | SESE |
| K810500 | BLOOD FREEZING BAG | Delmed, Inc. | Sep 23, 1981 | SESE |
| K811523 | PLASMA FLEX | Terumo America, Inc. | Sep 9, 1981 | SESE |
| K811449 | HAEMONETICS 1000ML COMPONENT BAG | Haemonetics Corp. | Jul 1, 1981 | SESE |
| K810711 | HAEMONETICS 600 ML. COMPONENT BAG | Haemonetics Corp. | May 8, 1981 | SESE |
| K810313 | HAEMONETICS 1400 ML THERAPEUTIC BAG | Haemonetics Corp. | Mar 31, 1981 | SESE |
| K801219 | PLASMAPOOLER | North American Biologicals, Inc. | Oct 31, 1980 | SESE |
| K801082 | GAMBRO HEMOFREEZE-BAG | Gambro, Inc. | Oct 31, 1980 | SESE |
| K792395 | PHARMAFLEX CRYOGENIC BAG | Pharmachem Corp. | Feb 26, 1980 | SESE |
| K792185 | PIASMA SAFE | Cry-O-Safe, Inc. | Dec 28, 1979 | SESE |
| K791673 | EMPTY TRANSFER BAG | Delmed, Inc. | Oct 23, 1979 | SESE |
| K781811 | TRANSFER PAK 4R 9006 | Travenol Laboratories, S.A. | Nov 8, 1978 | SESE |
| K780354 | CRYOCYTE PACK | Travenol Laboratories, S.A. | Jun 14, 1978 | SESE |
| K760952 | TERASAKI LYMPHOCYTE TRANSPORT KIT | Dravon Medical, Inc. | Jan 17, 1977 | SESE |
Top Applicants
- Haemonetics Corp. — 3 clearances
- Delmed, Inc. — 2 clearances
- Travenol Laboratories, S.A. — 2 clearances
- Alpha Therapeutic Corp. — 1 clearance
- Cry-O-Safe, Inc. — 1 clearance
